Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

Tobacco Use Disorder Clinical Trial

Official title:

Stress Response and Smoking Cessation in Depressed Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00129272
• Other study ID #: NIDA-15131-1
• Secondary ID: R01-15131-1DPMC
• Status: Recruiting
• Phase: Phase 2
• First received: August 4, 2005
• Last updated: September 2, 2009
• Start date: May 2004
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: Kathryn Mettman
• Phone: 214-648-5250
• Email: kathryn.mettman[@]utsouthwestern.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

Description:

Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.

Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.

Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment and at yearly intervals for up to 4 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

Inclusion Criteria:

• Has smoked at least 10 cigarettes each day for 3 or more months

• Weighs at least 90 lbs

• Motivated to quit smoking and has had at least one previous failed attempt

• Speaks, reads, and writes English

• Either diagnosed as depressed OR no history of a psychiatric disorder

Exclusion Criteria:

• History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry

• Currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry

• Psychotic symptoms

• Use of psychotropic medication(s)

• Serious medical condition

• Prior use of bupropion for smoking cessation

• Currently using other smoking cessation treatments

Study Design

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

Related Conditions & MeSH terms

• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion
150mg tablets taken orally twice daily.
• Placebo
Participants will receive placebo in this treatment group.

Behavioral:
• CBT Treatment
Participants will undergo nine weeks of behavioral modification therapy only.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

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	Smoking Behavior		nine weeks; six month post treamtent	No
Secondary	Withdrawal symptoms		nine weeks; six month post treatment	Yes