Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

• ClinicalTrials.gov Identifier: NCT02202499
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: July 25, 2019
• Last Update Posted: November 27, 2020
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: James and Esther King Biomedical Research Program; Pfizer
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

Tracking Information

• First Submitted Date: July 22, 2014
• First Posted Date: July 29, 2014
• Results First Submitted Date: October 26, 2017
• Results First Posted Date: July 25, 2019
• Last Update Posted Date: November 27, 2020
• Actual Study Start Date: July 17, 2014
• Actual Primary Completion Date: December 11, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2019)

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).

Original Primary Outcome Measures (submitted: July 25, 2014)

Number of Participants with Reduced Smoking Satisfaction [ Time Frame: 15 months ]

Number of participants with reduced smoking satisfaction per study arm. To document post-participation survey results to help plan future studies of Varenicline's effect on reducing smoking satisfaction.

Current Secondary Outcome Measures (submitted: July 24, 2019)

• 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.
• Rate of Intervention Adherence - Medication [ Time Frame: One month post treatment - approximately 20 weeks ]
  Percent of participants still using varenicline at time of analysis.
• 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.
• 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"
• 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"

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
• Official Title: Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial
• 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.

• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Smoking Cessation
• Tobacco Dependence

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 Name: 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.

Study Arms

• 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.
  Interventions:

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

  • Drug: Varenicline
  • Other: Laboratory Assessments
• 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.
  Interventions:

  • Drug: Varenicline
  • Other: Laboratory Assessments

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2016): 86
• Original Estimated Enrollment (submitted: July 25, 2014): 85
• Actual Study Completion Date: June 14, 2019
• Actual Primary Completion Date: December 11, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02202499
• Other Study ID Numbers: MCC-17654
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• Study Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Collaborators

• James and Esther King Biomedical Research Program
• Pfizer

Investigators

• Principal Investigator: Thomas Brandon, Ph.D.; H. Lee Moffitt Cancer Center and Research Institute

• PRS Account: H. Lee Moffitt Cancer Center and Research Institute
• Verification Date: November 2020