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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00135785

Collaborator

University of California, Los Angeles (Other)

Enrollment

Locations

Arms

Duration (Months)

36.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine	Drug: Bupropion Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Evaluation of Bupropion vs Placebo for the Treatment of Methamphetamine Dependence

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Bupropion	Drug: Bupropion
Placebo Comparator: 2 Placebo	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: 1

Bupropion

Drug: Bupropion

Placebo Comparator: 2

Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Addiction severity, Week 16 []
Drug use, Week 16 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Medical Center	Los Angeles	California	United States	90024
2	Rancho Cucamonga Clinic	Rancho Cucamonga	California	United States	91730

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)
University of California, Los Angeles

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00135785

Other Study ID Numbers:

NIDA-18185-2
P50-DA018185-2
DPMC

First Posted:

Aug 26, 2005

Last Update Posted:

Jan 12, 2017

Last Verified:

Sep 1, 2009

Additional relevant MeSH terms:

Bupropion

Study Results

No Results Posted as of Jan 12, 2017