Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Early Phase 1

Completed

Conditions: Smoking Cessation
Tobacco Dependence

Interventions: Drug: Varenicline
Other: Laboratory Assessments
Other: Counseling and Support Materials

Registration Number: NCT02202499

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Varenicline (SV)	Laboratory Assessments	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.
Extended Varenicline + Facilitated Extinction	Laboratory Assessments	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.
Extended Varenicline + Facilitated Extinction	Counseling and Support Materials	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.
Extended Varenicline (EV)	Laboratory Assessments	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.
Extended Varenicline + Facilitated Extinction	Varenicline	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.
Standard Varenicline (SV)	Varenicline	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.
Extended Varenicline (EV)	Varenicline	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.

Primary Outcome Measures

Name	Time	Method
Rate of Participant Retention	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 Outcome Measures

Name	Time	Method
Mean Smoking Satisfaction Score Per Group	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"
Mean Peak Craving Score Per Group	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"
Client Satisfaction Questionnaire (CSQ) Results	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.
Rate of Intervention Adherence - Medication	One month post treatment - approximately 20 weeks	Percent of participants still using varenicline at time of analysis.
Average Intervention Adherence - Cigarettes Per Day (CPD)	During last week of treatment, week 16	Average Cigarettes per Day across group, during last week of treatment.