Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions

March 21, 2019 updated by: University of Florida
Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum of 12 years of education
  • Must report typical daily smoking of > 10 cigarettes/day over the previous year
  • Must report a history of at least 3 years of regular smoking
  • Must provide carbon monoxide measures of at least 6.5 ppm
  • Must report a willingness to quit smoking

Exclusion Criteria:

  • Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
  • Must not meet criteria for other substance dependence or major psychiatric disorders.
  • Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
  • Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
  • Must not report current use of nicotine replacement therapies (i.e., occasions of > 4 h/week during a typical week, even if not used as a cessation aid)
  • Must not have used bupropion within the previous year
  • Must not report any past use (regardless of year) of varenicline
  • Women may not be breastfeeding, pregnant or intending to become pregnant during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: GTS-21
Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Drug: GTS-21
GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.
Other Names:
  • 3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A)
Placebo Comparator: Placebo
Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
Drug: Placebo
Oral placebo pills, compounded by the UF investigational pharmacy
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Change in Carbon Monoxide (CO) from baseline at weeks 5, 8
Time Frame: Change in baseline at Week 5, Week 8
Expired Carbon Monoxide levels will be quantified in parts per million.
Change in baseline at Week 5, Week 8
Change in Urine Cotinine (COT) from baseline at weeks 5, 8
Time Frame: Change in baseline at Week 5, Week 8
Cotinine excreted in urine will be quantified in ng/mL
Change in baseline at Week 5, Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8
Time Frame: Change in baseline at Week 5, Week 8
The Beck Depression Inventory will be used to quantify depressive symptomatology. The measure is a 21-item, self-report, multiple-choice inventory, with scores ranging from 0-63.
Change in baseline at Week 5, Week 8
Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8
Time Frame: Change in baseline at Week 5, Week 8
The State Anxiety Inventory will be used to quantify anxiety symptomatology. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.
Change in baseline at Week 5, Week 8
Change in State Anger (ANG-S) from baseline at weeks 5, 8
Time Frame: Change in baseline at Week 5, Week 8
The Spielberger State Anger Inventory will be used to assess state anger. The measure is a 20-item, self-report, multiple-choice inventory, with scores ranging from 20-80.
Change in baseline at Week 5, Week 8
Pill Count - Week 1
Time Frame: Week 1
Medication compliance will be assessed with pill counts.
Week 1
Pill Count - Week 5
Time Frame: Week 5
Medication compliance will be assessed with pill counts.
Week 5
Pill Count - Week 8
Time Frame: Week 8
Medication compliance will be assessed with pill counts.
Week 8
Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
The Minnesota Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60.
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1
Time Frame: Week 1
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 1
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2
Time Frame: Week 2
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 2
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3
Time Frame: Week 3
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 3
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4
Time Frame: Week 4
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 4
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5
Time Frame: Week 5
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 5
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6
Time Frame: Week 6
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 6
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7
Time Frame: Week 7
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 7
Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8
Time Frame: Week 8
The SAFTEE assesses potential side effects across a broad range of potential somatic effects. The measure includes 132 potential areas in which participants might report effects, including opportunities for the participant to describe otherwise unlisted option. Each area is scored on a 5-point scale.
Week 8
Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8
Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
The Profile of Mood States-2 (short-form for adults) The POMS 2 is a multi-dimensional, assessment of transient moods, and states of affect. The measure includes 35 items, each rated on a 5-point scale (0-4).
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Rapid Visual Information Processing task (Behavior) - Baseline
Time Frame: Baseline
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.
Baseline
Rapid Visual Information Processing task - (Behavior) - Week 8
Time Frame: Week 8
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include accuracy and reaction time.
Week 8
Rapid Visual Information Processing task - (EEG) - Baseline
Time Frame: Baseline
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Baseline
Rapid Visual Information Processing task - (EEG) - Week 8
Time Frame: Week 8
The Rapid Visual Information Processing task is an attention task. Subjects are instructed to detect and respond as quickly, yet as accurately, as possible when a target of three consecutive odd or even digits are presented. Digits are presented at the rate of approximately 100 per minute. Hits are separated by a varying number of stimuli (e.g., between 5 and 30 digits). Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Week 8
Measurement of GTS-21 Concentration in Blood - Week 5
Time Frame: Week 5
Blood samples will be collected and analyzed for their concentration of GTS-21.
Week 5
Measurement of GTS-21 Concentration in Blood - Week 8
Time Frame: Week 8
Blood samples will be collected and analyzed for their concentration of GTS-21.
Week 8
Trail Making Test A (TMT-A) - Baseline
Time Frame: Baseline
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Baseline
Trail Making Test A (TMT-A) - Week 5
Time Frame: Week 5
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Week 5
Trail Making Test A (TMT-A) - Week 8
Time Frame: Week 8
The Trail Making Test A consists of numbered 25 circles distributed over a sheet of paper. Participants draw a line between consecutive circles as quickly and accurately as possible. The dependent variable is time to completion of the task.
Week 8
Trail Making Test B (TMT-B) - Baseline
Time Frame: Baseline
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Baseline
Trail Making Test B (TMT-B) - Week 5
Time Frame: Week 5
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Week 5
Trail Making Test B (TMT-B) - Week 8
Time Frame: Week 8
The Trail Making Test B consists of 25 circles distributed over a sheet of paper, labeled with numbers (1-13) and letters (A-L). Participants draw a line between circles, alternating between consecutive numbers and letters (i.e., 1 to A, A to 2, 2 to B, etc.) as quickly and accurately as possible. The dependent variable is time to completion of the task.
Week 8
N-Back Working Memory Task (Behavior) - Baseline
Time Frame: Baseline
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.
Baseline
N-Back Working Memory Task (Behavior) - Week 8
Time Frame: Week 8
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include accuracy and reaction time.
Week 8
N-Back Working Memory Task (EEG) - Baseline
Time Frame: Baseline
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Baseline
N-Back Working Memory Task (EEG) - Week 8
Time Frame: Week 8
The 'n-back' test is a measure of working memory entailing the presentation of a stream of numbers, presented singly, and separated by neutral stimuli (i.e., "+"). Ss press a button when the presented stimulus is the same as the one that occurred 'n-back', i.e., some specific number back. The 'n-back' will vary across blocks (i.e., 1 or 2 back). A control condition, requiring Ss to press the button when a blank slide appears, will also be employed. Dependent variables will include electrophysiological measures gathered during task participation, including the peak and latency of the P3, P2, and N1 components.
Week 8
Simple Reaction Time Test - Baseline
Time Frame: Baseline
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Baseline
Simple Reaction Time Test - Week 5
Time Frame: Week 5
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Week 5
Simple Reaction Time Test - Week 8
Time Frame: Week 8
In this computerized task, subjects must press a button as quickly as possible each time a designed symbol appears on the screen. This test serves as a perceptual-motor control. The dependent measure is reaction time.
Week 8
Little Man Test - Baseline
Time Frame: Baseline
In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.
Baseline
Little Man Test - Week 8
Time Frame: Week 8
In this computerized mental rotation test, subjects must indicate the hand in which a simulated figure holds an object. The dependent measures are accuracy and reaction time.
Week 8
Visual-Perceptual Analysis Test - Baseline
Time Frame: Baseline
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Baseline
Visual-Perceptual Analysis Test - Week 5
Time Frame: Week 5
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Week 5
Visual-Perceptual Analysis Test - Week 8
Time Frame: Week 8
In this computerized task, subjects must distinguish which of three similar shapes differs from the other two. Dependent measures include accuracy and reaction time.
Week 8
Wisconsin Card Sorting Test - Baseline
Time Frame: Baseline
The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.
Baseline
Wisconsin Card Sorting Test - Week 8
Time Frame: Week 8
The Wisconsin Card Sort Test is a computerized task which requires subjects to match "cards" based on shifting matching rules which include color, shape, and number of symbols. The dependent measures for this task include accuracy and response time.
Week 8
Sternberg Short-Term Memory Test - Baseline
Time Frame: Baseline
The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.
Baseline
Sternberg Short-Term Memory Test - Week 8
Time Frame: Week 8
The Sternberg Short-Term Memory Test is a computerized task in which participants are shown four digits, presented one at a time, followed by a probe digit. They must determine if the probe digit was in the original set of digits, and recall the digits. The dependent variables are probe accuracy, number of correct recalls, and time to completion.
Week 8
Stroop Color Word Task - Baseline
Time Frame: Baseline
The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.
Baseline
Stroop Color Word Task - Week 8
Time Frame: Week 8
The Stroop Task is a measure of inhibitory control. Subjects are directed to name the colors words are printed in (i.e., "blue"), while ignoring the incongruent meaning of the words. The dependent measures include number correct and number completed.
Week 8
Digit Symbol Substitution Task - Baseline
Time Frame: Baseline
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Baseline
Digit Symbol Substitution Task - Week 5
Time Frame: Week 5
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Week 5
Digit Symbol Substitution Task - Week 8
Time Frame: Week 8
The Digit Symbol Substitution Task requires attention and set-switching. Subjects must translate between numbers and symbols, using a key provided. The dependent measure is number of correct responses completed.
Week 8
Metabolic Panel - Baseline
Time Frame: Baseline
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Baseline
Metabolic Panel - Week 2
Time Frame: Week 2
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Week 2
Metabolic Panel - Week 5
Time Frame: Week 5
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Week 5
Metabolic Panel - Week 8
Time Frame: Week 8
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Week 8
Metabolic Panel - Week 9 (Followup)
Time Frame: Week 9
Liver Function Test will measure a standard array of blood chemistries, including electrolytes, blood glucose, protein, liver enzymes (aminotransferase/alanine aminotransferase), bilirubin, creatinine, and blood urea nitrogen.
Week 9
Urinalysis - Baseline
Time Frame: Baseline
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Baseline
Urinalysis - Week 2
Time Frame: Week 2
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Week 2
Urinalysis - Week 5
Time Frame: Week 5
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Week 5
Urinalysis - Week 8
Time Frame: Week 8
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Week 8
Urinalysis - Week 9 (Followup)
Time Frame: Week 9
Standard urinalysis will be conducted, including urine pH, red cell count, white cell count, specific gravity, and bacteria content.
Week 9
Electrocardiogram - Baseline
Time Frame: Baseline
Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).
Baseline
Electrocardiogram - Week 1
Time Frame: Week 1
Standard electrocardiographic data will be collected, including heart rate (BPM) and time between start of the Q wave and end of the T wave (QT interval).
Week 1
Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
Time Frame: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Drug and alcohol use will be assessed using Timeline Followback procedures. Drug and alcohol use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Change in Blood Pressure from baseline at weeks 2, 5, 8, 9
Time Frame: Change in baseline at Week 2, Week 5, Week 8, Week 9
Systolic and Diastolic pressures will be collected.
Change in baseline at Week 2, Week 5, Week 8, Week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara J Nixon, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201500393
  • Nixon2015 (Other Identifier: Nixon)
  • R21DA038286 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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