Effectiveness of Bupropion Combined With Behavioral Therapy for Treating Methamphetamine Dependence - 2

Official Title: “A Randomized, Double-Blind, Placebo-Controlled Evaluation of Bupropion vs Placebo for the Treatment of Methamphetamine Dependence”

Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the brain. The purpose of this study is to determine the effectiveness of bupropion in combination with behavioral therapy for the treatment of methamphetamine addiction.

Methamphetamine is a drug that causes excess amounts of the neurotransmitters dopamine and norepinephrine to be released into the brain. This overload produces unusual alertness and feelings of elation. When the body undergoes methamphetamine withdrawal, it experiences a reduction in dopamine and norepinephrine. Bupropion is an antidepressant used for the treatment of depression and smoking cessation. Because it functions by increasing the release of dopamine and norepinephrine in the brain, bupropion is likely to decrease the negative effects of methamphetamine withdrawal. The purpose of this study is to evaluate the efficacy of bupropion combined with contingency management (CM) and cognitive behavioral counseling (CBT) as a means of treating methamphetamine dependence.

An initial 2-week screening process will involve participants providing urine samples and completing physical and psychological assessments. If deemed eligible for the remainder of this double-blind study, participants will be randomly assigned to receive either bupropion or placebo over the course of 12 weeks. Participants in both the bupropion and placebo groups will receive contingency management and cognitive behavioral counseling. Participants will report to one of two clinical research sites three times per week. At each visit, participants will be examined by the study staff, provide a urine sample, and receive individual cognitive behavioral counseling sessions. At the end of 12 weeks, treatment will be stopped. Participants will return to the study site 30 days later for evaluation and to be assessed for any possible lingering side effects.

Intervention(s) in this Clinical Trial

• Drug: Bupropion
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Bupropion
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Addiction severity, Week 16
• Drug use, Week 16

Inclusion Criteria:

• Meets DSM-IV criteria for methamphetamine dependence
• Females must use an effective method of contraception

Exclusion Criteria:

• History of or current medical condition that might interfere with safe participation, such as active tuberculosis, unstable heart or liver disease, unstable diabetes, symptomatic AIDS (non-symptomatic HIV infection is not an exclusion), or greater than 8 times the upper limit of normal in liver screening function tests (SGOT or SGPT)
• Current neurological disorder (e.g., organic brain disease, dementia)
• Major psychiatric disorder unrelated to substance abuse, such as schizophrenia or bipolar disorder (assessed by the SCID and a medical history)
• Suicide attempt within the month prior to enrollment and/or currently suicidal (assessed by the SCID and the BDI II)
• Currently on prescription medication that might interact with the study drug
• Currently dependent on cocaine, opiates, alcohol, or benzodiazepines, as defined by DSM-IV-TR criteria
• History of alcohol dependence within past three years
• History of seizure disorders
• History of anorexia or bulimia
• Current hypertension uncontrolled by medication
• History of sensitivity to bupropion
• Pregnant or breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

Steve Shoptaw, Ph.D. Principal Investigator University of California, Los Angeles  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00135785

Study ID Number: NIDA-18185-2

ClinicalTrials.gov Identifier: NCT00135785

Health Authority: United States: Federal Government