Phase 3
N=31
Project Q Pilot: Smoking Cessation for Light Smokers
Tobacco Use Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03416621 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Completion of at Least 2 Study Visits — 10; 7; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cognitive behavioral cessation counseling (Behavioral); Counseling and placebo drug intervention (Behavioral); Counseling and active drug intervention (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Completion of at Least 2 Study Visits |
10; 7; 1 | — |
| PRIMARY Number of Participants Who Rated the Intervention Acceptable |
23 | — |
| SECONDARY Number of Participants With Validated Cessation |
2; 0; 0 | — |
Summary
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
Eligibility Criteria
Inclusion Criteria
- Age: ≥18 years old
- Able to read and understand English or Spanish
- Cognitively able to provide informed consent
- Smoke 1-10 cigs/day on at least 4 days in the past month
- Express a desire to quit smoking in the next 30 days
- Access to a cell phone that can send and receive SMS text messages and take and send pictures
Exclusion Criteria
- Hypertension with a screening blood pressure over 160/100;
- Hypotension with a screening blood pressure of systolic 9 or > 0 on item #9
- Bulimia or anorexia;
- Pregnant or nursing;
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive for Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless prescribed for management of acute symptoms (tooth extraction, recent surgery);
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants (MAOIs, St. John's Wort), lithium, anti-psychotics, or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
- Use of cigars, cigarillos, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco , or e-cigarettes within the past 30 days;
- Positive result on AUDIT-C;
- Self-report of marijuana use ≥ 4 days per week;
- Significant adverse reaction to D-cycloserine in the past;
- Current or recent (in the past 30 days) participation in another smoking study at our Center or another research facility
Data sourced from ClinicalTrials.gov (NCT03416621). 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.