Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

NCT02202499 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: MCC-17654
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Tobacco Dependence

Keywords

pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Client Satisfaction Questionnaire (CSQ) Results

  One month post treatment - approximately 20 weeks

• Rate of Intervention Adherence - Medication

  One month post treatment - approximately 20 weeks

• Average Intervention Adherence - Cigarettes Per Day (CPD)

  During last week of treatment, week 16

• Mean Peak Craving Score Per Group

  Across 4 pre-quit weeks

• Mean Smoking Satisfaction Score Per Group

  Across 4 pre-quit weeks

Study Arms (3)

Extended Varenicline + Facilitated Extinction

ACTIVE COMPARATOR

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; Other: Counseling and Support Materials; Other: Laboratory Assessments

Standard Varenicline (SV)

ACTIVE COMPARATOR

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; Other: Laboratory Assessments

Extended Varenicline (EV)

ACTIVE COMPARATOR

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; Other: Laboratory Assessments

Interventions

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.

Also known as: Chantix™

Extended Varenicline (EV); Extended Varenicline + Facilitated Extinction; Standard Varenicline (SV)

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.

Extended Varenicline + Facilitated Extinction

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.

Extended Varenicline (EV); Extended Varenicline + Facilitated Extinction; Standard Varenicline (SV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• James and Esther King Biomedical Research Program: collaborator
• Pfizer: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Varenicline; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Thomas Brandon
• Organization: H. Lee Moffitt Cancer Center and Research Institute

thomas.brandon@moffitt.org

813-745-1750

Study Officials

• Thomas Brandon, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 29, 2014
• Study Start: July 17, 2014
• Primary Completion: December 11, 2015
• Study Completion: June 14, 2019
• Last Updated: November 27, 2020
• Results First Posted: July 25, 2019

Record last verified: 2020-11

Locations

US (1)