Phase 2
Completed N=95
Bupropion in Helping Adults Stop Smoking
Source: ClinicalTrials.gov NCT00534001 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Prequit Change in Cigarettes Per Day — -2.6; -3.9 Cigarettes Per Day
Summary
RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine withdrawal. Giving bupropion over a longer period of time may be effective in helping people stop smoking.
PURPOSE: This randomized phase II trial is studying how well bupropion works in helping adults stop smoking.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prequit Change in Cigarettes Per Day |
-2.6; -3.9 | — |
| SECONDARY Abstinence |
25; 15 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Currently smokes ≥ 15 cigarettes per day for at least 1 year
- Motivated to quit smoking within the next 3 months
PATIENT CHARACTERISTICS:
- Willing to attend clinic visits
- Willing to refrain from nicotine replacement therapy (NRT) use during study participation
- Able to speak and read English fluently
- Has a home telephone and plans to reside in Western New York for the next year
- Not pregnant or nursing
- Negative pregnancy test
- Not planning a pregnancy
- Fertile patients must use effective contraception during and for 3 months after study participation
- No history of chronic renal or hepatic disease
- No history of head trauma or seizure
- No history of a seizure disorder, brain tumor, or CNS tumor
- No history of or currently diagnosed bulimia or anorexia nervosa
- No history of psychotic disorder
- No diabetes requiring oral hypoglycemics or insulin
- No excessive use of alcohol or alcoholism
- No current addiction to opiates, cocaine, or stimulants
- No poorly controlled hypertension (i.e., systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 110 mm Hg)
- No allergy to bupropion hydrochloride
- No other surgical or medical condition that may significantly alter absorption, distribution, metabolism, or excretion of bupropion hydrochloride
- No history of noncompliance to medical regimens
- No other clinical contraindication
- No major depressive disorder
PRIOR CONCURRENT THERAPY:
- At least 14 days since prior and no concurrent monoamine oxidase inhibitor
- No recent discontinuation of a benzodiazepine
- No concurrent Hypericum perforatum (St. John's wort)
- No other concurrent drugs containing bupropion hydrochloride (e.g., Wellbutrin or Zyban)
- No concurrent antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants or anorectics, or levodopa
- No concurrent active treatment for cancer (e.g., chemotherapy or radiotherapy)
Data sourced from ClinicalTrials.gov (NCT00534001). 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.