Clinical trial NCT02202499: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Tobacco Dependence
Keywords: pharmacotherapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
name: Pfizer
First posted: 2014-07-29
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Rate of Participant Retention
timeFrame: End of post treatment follow-up period of 3 months - approximately 28 weeks
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ) Results
timeFrame: One month post treatment - approximately 20 weeks
measure: Rate of Intervention Adherence - Medication
timeFrame: One month post treatment - approximately 20 weeks
measure: Average Intervention Adherence - Cigarettes Per Day (CPD)
timeFrame: During last week of treatment, week 16
measure: Mean Peak Craving Score Per Group
timeFrame: Across 4 pre-quit weeks
measure: Mean Smoking Satisfaction Score Per Group
timeFrame: Across 4 pre-quit weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: