Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial

NCT00728312 | Withdrawn Phase 4

• 1 other identifier: CDA-2-017-08S
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine; Therapeutics; Psychopharmacology; Amphetamine

Outcome Measures

Primary Outcomes (1)

• Reduction in methamphetamine use as measured weekly by the Time Line Follow Back (TLFB) and Urine Drug Screens

  Assessed weekly for 12 weeks

Secondary Outcomes (1)

• Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS)

  Assessed weekly for 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Aripiprazole (Abilify), flexible dosing 5-15 mg per day

Drug: Aripiprazole

2

PLACEBO COMPARATOR

Placebo look-alike, flexible dosing 5-15 mg per day

Drug: Placebo

Interventions

Aripiprazole DRUG

12 week comparison of active medication (aripiprazole 5-15 mg per day) versus Placebo (placebo look-alike 5-15 mg per day)

Also known as: Abilify

1

Placebo DRUG

12 week comparison of placebo 5-15 mg per day (pill which contains no active medication) versus active medication (aripiprazole 5-15 mg per day)

2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Syed Pirzada Sattar, MD

  VA Medical Center, Omaha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 26, 2015

Record last verified: 2015-06