Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214 (TC-5214)

March 21, 2012 updated by: AstraZeneca

A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users

This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to placebo, ketamine, and phentermine in healthy recreational polydrug users.

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Withdrawn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

A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users.

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 1

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current recreational polydrug users with experience with at least 2 drug classes of abuse.
  • At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA [ecstasy], LSD, mesacline, or psilocybin).
  • Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates).
  • Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening.
  • Must pass qualification phase eligibility criteria.

Exclusion Criteria:

  • Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation).
  • Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up.
  • Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
  • Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation.
  • Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours.
  • Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

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.
Experimental: Crossover Treatment Sequence 1
Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 2
Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 3
Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 4
Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 5
Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 6
Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 7
Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 8
Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 9

Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7:

Phentermine 45 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 10
Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 11
Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 12
Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 13
Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 14
Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg

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
Momentary Drug Liking VAS maximum effect (Emax)
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

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
Momentary Drug Liking VAS minimum effect (Emin)
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking" The minimum value recorded is chosen.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Drug Liking VAS time-weighted mean (TWmean)
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". Time weighted average score is calculated.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Overall Drug Liking VAS maximum effect ( Emax)
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Overall Drug Liking VAS (Emin)
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The minimum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Overall Drug Liking VAS 10-hour mean score
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
Overall Drug Liking VAS 24-hour mean score
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Take Drug Again VAS Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Take Drug Again VAS 10-hour mean score
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
Take Drug Again VAS 24-hour mean score
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Subjective Drug Value Emax
Time Frame: 10 and 24 hours post dose
The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values.
10 and 24 hours post dose
Subjective Drug Value 10 hour mean score
Time Frame: 10 hours post dose
The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values
10 hours post dose
Subjective Drug 24 hour mean scores
Time Frame: 10 and 24 hours post dose
The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values
10 and 24 hours post dose
High VAS Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
High VAS TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Good Effects VAS Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Good Effects VAS TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bad Effects VAS Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bad Effects VAS TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated.
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI dysphoria scale (LSD) Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI dysphoria scale (LSD) TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI sedation scale (PCAG) Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI sedation scale (PCAG) TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Alertness/Drowsiness VAS Emin (drowsiness)
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The minimum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Alertness/Drowsiness VAS TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The time weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Any Effects VAS Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Any Effects VAS TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bowdle VAS Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bowdle VAS TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI A scale Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI A scale TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI Phentermine and Benzedrine Group scale (BG) Emax
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The maximum value recorded is chosen
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI Phentermine and Benzedrine Group scale (BG) TWmean
Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Questionnaire to assess possible addiction. The time-weighted mean value is calculated
0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

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.
AstraZeneca

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.
  • Study Director: Hans A Eriksson, MD, AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden
  • Principal Investigator: Pierre Geoffroy, MDCM, MSC, FCFP, Syneos Health
  • Study Director: Brendan Smyth, MD, AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437

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

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.
January 1, 2012

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.
April 1, 2012

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.
April 1, 2012

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).
December 6, 2011

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.
December 23, 2011

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.
December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

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 22, 2012

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, 2012

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, 2012

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.
  • D4130C00022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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