A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation
- Determine the feasibility of conducting a full-scale clinical trial to evaluate whether
extending the duration of pre-cessation bupropion hydrochloride enhances smoking
cessation, as measured by 3-month prolonged abstinence rates, in adult smokers.
- Assess baseline smoking and mood characteristics (nicotine dependence, smoking history,
anxiety, and depression).
- Assess measures to address the hypothesized extinction mechanism (subjective effects of
smoking, collection of cigarette butts for an assessment of nicotine and tar exposure,
craving for smoking, and expectations for the consequences of smoking).
- Assess changes in affective state as measured by Withdrawal Symptoms Checklist and by
Positive and Negative Affect Schedule (PANAS) questionnaire.
- Assess side effects, pill counts, and changes in daily smoking rate.
- Assess mental health, personality traits, interpersonal skills, demand simulation,
impulsivity, motivation, and perceived stress using validated measures.
OUTLINE: Participants are stratified according to gender. Participants are randomized to 1
of 2 pre-cessation intervention arms.
- Arm I (1-week run-in): Participants receive an oral placebo once or twice daily in
weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4.
Participants also undergo 90-minute behavioral group counseling sessions once in weeks
1, 2, and 4.
- Arm II (4-week run-in): Participants receive oral bupropion hydrochloride once or twice
daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling
sessions once in weeks 1, 2, and 4.
In both arms, participants are asked to quit smoking (target quit date) in week 5. All
participants then receive oral bupropion hydrochloride once or twice daily in weeks 5-11 and
undergo 90-minute behavioral group counseling sessions once in weeks 5, 7, and 9.
Participants complete questionnaires to collect information on tobacco use history, health
habits, depression, anxiety scales/symptoms, and sociodemographics at baseline. Participants
also complete a series of validated questionnaires about smoking patterns, smoking
satisfaction, mental health, personality traits, interpersonal skills, demand simulation,
impulsivity, motivation, and perceived stress at baseline and then periodically during
study. Participants undergo saliva sample collection at baseline and then periodically
during study. Samples are analyzed for the presence of cotinine. Buccal cells are also
collected at baseline for subsequent DNA analyses. Cigarette butts from the first cigarette
of the day, including the quit day, are collected during group counseling sessions in weeks
1, 2, 4, and 5 and are assessed for a marker that indicates the amount of nicotine and tar
After finishing study treatment, participants are followed at 6 and 12 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Effect of bupropion hydrochloride on changes in smoking behavior as well as smoking satisfaction, craving, and withdrawal as determined during the pre-cessation phase
Martin Mahoney, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|