Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial

• Status: Withdrawn
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether treatment with Aripiprazole leads to a reduction in methamphetamine craving and use in patients diagnosed with methamphetamine dependence. Patients presenting at the Omaha VA Medical Center for treatment of methamphetamine dependence, and meet inclusion criteria for the study will be invited to participate. Participation in the study will last for approximately 14 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Amphetamine; Aripiprazole; Methamphetamine

Criteria

Inclusion Criteria:

• Veterans, ages 19 to 65, willing and able to provide informed consent

• Primary diagnosis of methamphetamine dependence as determined by the Structured Clinical Interview for the DSM-IV (SCID-II). They must not have current dependence with other substances such as alcohol, cocaine, opiates, and marijuana. However, abuse of these drugs will be allowed for this study.

• Within 30 days of last use of methamphetamine.

• Must have been using at least once a month for the past three months at enrollment.

• Present without any current intoxication effects of methamphetamine to provide informed consent at the time of the baseline session

• No diagnosis of schizophrenia by the SCID. If they have a history of a mood or anxiety disorder, they will not be in active pharmacological treatment for at least the previous two weeks

• Must not be suicidal or homicidal

• Not currently taking psychotropics (antipsychotic, mood stabilizing, anti-anxiety, or antidepressant medications)

• Female subjects must not be pregnant or lactating, and must be using approved birth control methods if of child bearing potential

• No medical contraindications (such as recent myocardial infarctions, cerebrovascular accidents, or abnormal lab values above 3 x normal ranges)

• No unstable diabetes or current fasting blood glucose test >140 mg/dl

• No diagnosis of dementia

• Must have stable address and access to a telephone

Exclusion Criteria:

• Inability or unwillingness to provide consent

• Medical or psychiatric instability, requiring inpatient treatment

• Previous reported allergic or adverse reaction to aripiprazole

• Being under an involuntary commitment for in/outpatient psychiatric treatment