Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Dependence
• Intervention / Treatment: Drug: Varenicline; Other: Counseling and Support Materials; Other: Laboratory Assessments

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extended Varenicline + Facilitated Extinction; Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive 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. All groups will undergo periodic laboratory assessments and surveys.	Drug: Varenicline; 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™; Other: Counseling and Support Materials; 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.; Other: Laboratory Assessments; 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.
Active Comparator: Standard Varenicline (SV); Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.	Drug: Varenicline; 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™; Other: Laboratory Assessments; 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.
Active Comparator: Extended Varenicline (EV); Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.	Drug: Varenicline; 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™; Other: Laboratory Assessments; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Participant Retention	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).	End of post treatment follow-up period of 3 months - approximately 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ) Results	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.	One month post treatment - approximately 20 weeks
Rate of Intervention Adherence - Medication	Percent of participants still using varenicline at time of analysis.	One month post treatment - approximately 20 weeks
Average Intervention Adherence - Cigarettes Per Day (CPD)	Average Cigarettes per Day across group, during last week of treatment.	During last week of treatment, week 16
Mean Peak Craving Score Per Group	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"	Across 4 pre-quit weeks
Mean Smoking Satisfaction Score Per Group	Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"	Across 4 pre-quit weeks

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Pfizer; James and Esther King Biomedical Research Program

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2014
• Primary Completion (Actual): December 11, 2015
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: pharmacotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: MCC-17654

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No