Clinical trial NCT00129272: Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Official title: Stress Response and Smoking Cessation in Depressed Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Keywords: adolescents, cigarettes, smoking, tobacco
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-08-11
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Behavior
timeFrame: Nine weeks
Secondary outcomes:
measure: Withdrawal Symptoms
timeFrame: Nine weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Medical Center
name: Uma Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: