Early Phase 1
Completed N=62
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
Smoking Cessation · Tobacco Dependence
Source: ClinicalTrials.gov NCT02202499 ↗
Enrolled (actual)
62
Serious AEs
3.5%
Results posted
Jul 2019
Primary outcomePrimary: Rate of Participant Retention — 15; 16; 19 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Participant Retention |
15; 16; 19 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ) Results |
30.33; 30.80; 30.47 | — |
| SECONDARY Rate of Intervention Adherence - Medication |
80; 80; 84 | — |
| SECONDARY Average Intervention Adherence - Cigarettes Per Day (CPD) |
17.58; 14.95; 11.05 | — |
| SECONDARY Mean Peak Craving Score Per Group |
4.64; 6.34; 4.56 | — |
| SECONDARY Mean Smoking Satisfaction Score Per Group |
3.37; 5.22; 2.59 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02202499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.