Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202499
• Other study ID #: MCC-17654
• Status: Completed
• Phase: Early Phase 1
• Start date: July 17, 2014
• Est. completion date: June 14, 2019

Study information

• Verified date: November 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 14, 2019
• Est. primary completion date: December 11, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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:
• 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.
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	James and Esther King Biomedical Research Program, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of Intervention Adherence - Medication	Percent of participants still using varenicline at time of analysis.	One month post treatment - approximately 20 weeks
Secondary	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
Secondary	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
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trials website