Effectiveness of Bupropion for Treating Nicotine Dependence in Young People - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00129272

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Stress Response and Smoking Cessation in Depressed Youth

Resource links provided by NLM:

MedlinePlus related topics: Smoking Smoking and Youth

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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
1: Active Comparator Participants who will be placed in the active medication treatment group	Drug: Bupropion 150mg tablets taken orally twice daily.
2: Placebo Comparator Participants who will be placed in the placebo treatment group	Drug: Placebo Participants will receive placebo in this treatment group.
3: Experimental 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

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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Uma Rao, MD

University of Texas Medical Center

More Information

No publications provided

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

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pharmacologic Actions

Mental Disorders
Therapeutic Uses
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010