Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00129272
First received: August 4, 2005
Last updated: September 2, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Tobacco Use Cessation
Tobacco Use Disorder
Drug: Bupropion
Drug: Placebo
Behavioral: CBT Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress Response and Smoking Cessation in Depressed Youth

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Smoking Behavior [ Time Frame: nine weeks; six month post treamtent ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Withdrawal symptoms [ Time Frame: nine weeks; six month post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: May 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants who will be placed in the active medication treatment group
Drug: Bupropion
150mg tablets taken orally twice daily.
Placebo Comparator: 2
Participants who will be placed in the placebo treatment group
Drug: Placebo
Participants will receive placebo in this treatment group.
Experimental: 3
Participants who will receive cognitive behavioral treatment only
Behavioral: CBT Treatment
Participants will undergo nine weeks of behavioral modification therapy only.

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 and at yearly intervals for up to 4 years.

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129272

Contacts
Contact: Kathryn Mettman 214-648-5250 kathryn.mettman@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390 9101
Contact: Kathryn Mettman    214-648-5250    teenhealth@utsouthwestern.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: Uma Rao, MD University of Texas Medical Center
  More Information

No publications provided

Responsible Party: Dr. Uma Rao, M.D., University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00129272     History of Changes
Other Study ID Numbers: NIDA-15131-1, R01-15131-1, DPMC
Study First Received: August 4, 2005
Last Updated: September 2, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014