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Phase 2 Completed N=95 Randomized Other

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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