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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Methamphetamine

Treatments

Drug: Bupropion

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00135785

NIDA-18185-2

P50-DA018185-2

DPMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

73 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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