Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

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.

• Smoking Cessation
• Tobacco Dependence

• 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.

• 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

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.

• James and Esther King Biomedical Research Program
• Pfizer