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Completed

NCT Number: NCT02202499

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Tobacco Dependence Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session.

Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Smoke at least 10 cigarettes daily for the past year
  • Expired-air carbon monoxide (CO) > 8 ppm
  • Medically eligible to receive varenicline
  • Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking.

Exclusion criteria

  • Are pregnant or lactating
  • Have renal dysfunction
  • Have a history of seizures
  • Are medically at risk in the judgment of the study physician
  • Have ever used varenicline
  • Have used other smoking cessation medications within the past three months
  • Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders)
  • Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015).
  • We must limit the number of participants from the same street address to 1.

Treatment and study plan

Varenicline

Drug

All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.

Other names: Chantix™

Counseling and Support Materials

Other

Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.

Laboratory Assessments

Other

The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.

Primary outcomes

  1. Rate of Participant Retention

    Time frame: End of post treatment follow-up period of 3 months - approximately 28 weeks

    Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).

Secondary outcomes

  1. Client Satisfaction Questionnaire (CSQ) Results

    Time frame: One month post treatment - approximately 20 weeks

    Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.

  2. Rate of Intervention Adherence - Medication

    Time frame: One month post treatment - approximately 20 weeks

    Percent of participants still using varenicline at time of analysis.

  3. Average Intervention Adherence - Cigarettes Per Day (CPD)

    Time frame: During last week of treatment, week 16

    Average Cigarettes per Day across group, during last week of treatment.

  4. Mean Peak Craving Score Per Group

    Time frame: Across 4 pre-quit weeks

    Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was "none", 5 "medium" and 10 "very high/strong"

  5. Mean Smoking Satisfaction Score Per Group

    Time frame: Across 4 pre-quit weeks

    Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • James and Esther King Biomedical Research Program
  • Pfizer

Registry information

Official study title

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2019
First posted
Jul 29, 2014
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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