Nicotine Withdrawal and Reward Processing (NicWith)

May 6, 2024 updated by: University of Oklahoma
This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.

Study Overview

Status

Status

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

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.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

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.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Hardesty Center for Clinical Research and Neuroscience

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Generally healthy
  2. Age 21-55
  3. Right-handed using a three-item scale
  4. Daily smoker of ≥ 6 cigarettes/day
  5. Smoking regularly for ≥ 1 year
  6. Have a smartphone capable of running the MetricWire application
  7. Able to read and understand English
  8. Able to identify at least 6 pleasurable activities they do not do concurrently with smoking or associate with smoking.
  9. Able to identify at least 6 unique locations/scenarios they do associate with smoking

Exclusion Criteria:

  1. Planning to quit smoking within the next 60 days
  2. Currently seeking or receiving treatment for smoking cessation
  3. Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
  4. Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.

  5. Positive toxicology screen for illicit drugs

    1. Marijuana will be tested for but will not be exclusionary
    2. Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
    3. Participants with valid prescriptions who report using the medication as directed and meet all other eligibility criteria may be allowed to participate at the PI's discretion
  6. Current use of antipsychotic or stimulant medications.

  7. Significant health problems or those that would impact scientific goals of the project, including (but not limited to):

    1. Cancer, Bronchitis, Emphysema, COPD
    2. Asthma or Breathing Problems
    3. Insulin-Dependent Diabetes
    4. Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
    5. Systolic Blood Pressure > 160, Diastolic Blood Pressure > 100, HR > 115 bpm (one re-screen allowed).
    6. Glaucoma, color blindness or an uncorrected vision problem
    7. Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
    8. History of stroke, brain tumor, seizure disorder, or traumatic brain injury
    9. Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
    10. Claustrophobia
    11. Weight > 350 pounds or unable to fit in the MRI scanner bore
    12. Current psychotic disorder, alcohol use disorder or drug use disorder for drugs other than cannabis (moderate or severe only, mild is allowable at PI's discretion). AUD and DUD in remission are also allowable at PI's discretion.
    13. Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
  8. Current enrollment in another smoking research study or having participated in a study involving daily use of Spectrum cigarettes or other reduced nicotine products within the past three months
  9. Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)

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: None (Open Label)

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.
Other: Smoking Abstinence
Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing
Other: Smoking Abstinence
Participants will abstain from smoking for 24 hours
Other: Ad Lib Smoking
Participants will continue smoking as usual (i.e. "ad lib") before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing.
Other: Ad Lib Smoking
Participants will continue smoking as usual (i.e. ad lib) in the day leading up to the scan and smoke one cigarette of their own brand immediately prior to scanning.

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
Blood Oxygen Level Dependent (BOLD) Activation
Time Frame: Approximately 2-4 weeks
BOLD activation in brain reward network regions
Approximately 2-4 weeks
Ecological Momentary Assessment (EMA) Pleasure Ratings
Time Frame: 2-4 weeks
Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase
2-4 weeks

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 Oklahoma

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)
Oklahoma State University

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 (Actual)

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.
June 2, 2022

Primary Completion (Actual)

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.
March 29, 2024

Study Completion (Actual)

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 15, 2024

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).
September 3, 2021

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.
September 3, 2021

First Posted (Actual)

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.
September 13, 2021

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.
May 8, 2024

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.
May 6, 2024

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.
May 1, 2024

More Information

Terms related to this study

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.
  • K23DA042898 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with relevant administrative offices to obtain guidance regarding any required Data Use Agreements as needed.

IPD Sharing Time Frame

We anticipate making data available within 6 months of study completion. It will be available for an indefinite period of time.

IPD Sharing Access Criteria

Contact PI for details.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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