NCT00534001 · REGISTRY CONDITION SEARCH

Bupropion in Helping Adults Stop Smoking

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-05-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Prequit Change in Cigarettes Per Day

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outcome · POSTED

Abstinence

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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)
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: bupropion hydrochloride
Other: placebo
label
Arm I (1-week run-in)
type
EXPERIMENTAL
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.
intervention Names
Drug: bupropion hydrochloride
label
Arm II (4-week run-in)
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I (1-week run-in)
Arm II (4-week run-in)
description
Given orally
name
bupropion hydrochloride
type
DRUG
arm Group Labels
Arm I (1-week run-in)
description
Given orally
name
placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

OTHER

Enrollment

count: 95
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Prequit Change in Cigarettes Per Day
measure
Prequit Change in Cigarettes Per Day
time Frame
3-Week PreQuit Drug Manipulation Phase

secondary Outcomes

description
Bioverified 4-week continuous abstinence
measure
Abstinence
time Frame
4 weeks

Full study description

brief 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.
detailed Description: OBJECTIVES: Primary * 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. Secondary * 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 consumed. After finishing study treatment, participants are followed at 6 and 12 months.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice