Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Completed; Early Phase 1

Conditions: Tobacco Dependence; Smoking Cessation

Treatments: Drug: Varenicline; Other: Counseling and Support Materials; Other: Laboratory Assessments

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02202499

MCC-17654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 3 patient groups

Extended Varenicline + Facilitated Extinction

Active Comparator group

Description:

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.

Treatment:

Other: Counseling and Support Materials

Other: Laboratory Assessments

Drug: Varenicline

Standard Varenicline (SV)

Active Comparator group

Description:

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.

Treatment:

Other: Laboratory Assessments

Drug: Varenicline

Extended Varenicline (EV)

Active Comparator group

Description:

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.

Treatment:

Other: Laboratory Assessments

Drug: Varenicline