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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Primary Purpose

Tobacco Dependence

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring Randomized, Double-blind, Placebo-controlled

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: More than 100 lbs IQ greater than 80 General good health Not pregnant Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime Smokers: Smoke more than 6 cigarettes per day for at least 6 months Exclusion Criteria: Cardiac, Central Nervous System (CNS) or severe psychiatric disorder Psychoactive medications (including nicotine replacement) Substance use disorder

Sites / Locations

  • Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active medication

Placebo

Arm Description

300mg bupropion HCL

Placebo pill

Outcomes

Primary Outcome Measures

Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure

Secondary Outcome Measures

Reduction of smoking-related urges and cravings.

Full Information

First Posted
November 1, 2005
Last Updated
September 22, 2016
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00248118
Brief Title
Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Official Title
Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
PI left NIH
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms in the maintenance of smoking in adolescents.
Detailed Description
This 10-week study consists of an unassisted (pretrial) acute tobacco withdrawal (AW) phase and a 7-week randomized double-blind placebo-controlled trial of bupropion (300 mg/day) for tobacco dependence. Neuropsychological examinations will be conducted at baseline, during acute withdrawal, and during treatment (incl. early withdrawal) with bupropion. We expect smoking cessation in approximately 25% of the active medication group and significant overall smoking reduction. We postulate that bupropion will also reduce the irritability, depressed mood and anxiety symptoms that typically occur during tobacco withdrawal. We expect to observe optimal cognitive performance, (i.e., attention, memory), and affective state during satiety, impairment during pre-treatment abstinence, and intermediate level cognitive performance in the abstinent active-treatment group. Because limited data are available on cognitive tasks in adolescent smokers, a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Randomized, Double-blind, Placebo-controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active medication
Arm Type
Active Comparator
Arm Description
300mg bupropion HCL
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin, Zyban
Intervention Description
During treatment phase, participants will take 300 mg bupropion or placebo daily.
Primary Outcome Measure Information:
Title
Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Reduction of smoking-related urges and cravings.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: More than 100 lbs IQ greater than 80 General good health Not pregnant Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime Smokers: Smoke more than 6 cigarettes per day for at least 6 months Exclusion Criteria: Cardiac, Central Nervous System (CNS) or severe psychiatric disorder Psychoactive medications (including nicotine replacement) Substance use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric T. Moolchan, M.D.
Organizational Affiliation
National Institute on Drug Abuse, Intramural Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

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