Bupropion in Helping Adults Stop Smoking

April 24, 2017 updated by: Roswell Park Cancer Institute

A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: placebo
Given orally
Drug: bupropion hydrochloride
Given orally
Experimental: 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.
Drug: bupropion hydrochloride
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prequit Change in Cigarettes Per Day
Time Frame: 3-Week PreQuit Drug Manipulation Phase
Prequit Change in Cigarettes Per Day
3-Week PreQuit Drug Manipulation Phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence
Time Frame: 4 weeks
Bioverified 4-week continuous abstinence
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Martin Mahoney, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000565103
  • I 57805 (Other Identifier: Roswell Park Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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