Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Tobacco Dependence Clinical Trial

Official title:

Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00248118
• Other study ID #: 999903382
• Secondary ID: 03-DA-N382
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 1, 2005
• Last updated: September 22, 2016
• Start date: January 2005
• Est. completion date: May 2008

Study information

• Verified date: September 2016
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: May 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion
During treatment phase, participants will take 300 mg bupropion or placebo daily.

Locations

Country	Name	City	State
United States	Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure		7 weeks	Yes
Secondary	Reduction of smoking-related urges and cravings.		7 weeks	Yes