Clinical trial · Interventional
Bupropion in Helping Adults Stop Smoking
A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation
NCT00534001CI-TRIAL-00027826completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bupropion hydrochloride | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (1-week run-in)
- description
- 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.
- interventionNames
- Drug: bupropion hydrochloride
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II (4-week run-in)
- description
- 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.
- interventionNames
- Drug: bupropion hydrochloride
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.