Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals
3 other identifiers
interventional
90
1 country
1
Brief Summary
Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among men who have sex with men (MSM), putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. This study is a randomized, double-blind, placebo-controlled trial of the medication aripiprazole for methamphetamine-using individuals, including MSM, and will assess efficacy, acceptability, tolerability, safety, and adherence to study medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2007
CompletedFirst Posted
Study publicly available on registry
July 6, 2007
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
March 24, 2014
CompletedMarch 24, 2014
February 1, 2014
3 years
July 5, 2007
December 12, 2012
February 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.
To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.
Final study visit at week 12
To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.
To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps \[MEMS or Medication Event Monitoring System\]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100\* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.)
Adherence as determined by MEMS (throughout study, up to 12 weeks)
To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.
Total reported adverse events (throughout study, up to 12 weeks)
Study Arms (2)
Aripiprazole
EXPERIMENTALAripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
Placebo
PLACEBO COMPARATORPlacebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
Interventions
Eligibility Criteria
You may qualify if:
- HIV-negative by rapid test, or documentation of HIV infection with a laboratory result of a positive HIV test;
- diagnosed with methamphetamine dependence as determined by SCID;
- interested in stopping or reducing methamphetamine use;
- at least one methamphetamine-positive urine during screening and run-in period;
- no current acute illnesses requiring prolonged medical care;
- no chronic illnesses that are likely to progress clinically during trial participation;
- able and willing to provide informed consent and to be followed over trial period;
- age 18-60 years;
- baseline CBC, total protein, albumin, glucose, lipid panel, alk phos, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by investigator in conjunction with symptoms, physical exam, and medical history.
- if sex assigned at birth was female and able to become pregnant: agrees to use birth control by any of the following methods - hormonal patch, pills, or injections; IUD; diaphragm; condoms; or abstinence.
You may not qualify if:
- has a psychiatric disorder as assessed by SCID that in the opinion of evaluating clinician would make the study participation unsafe, or make adherence to study protocol untenable. Conditions include current major depression, current suicidal ideation, bipolar disorder, dementia, or acute psychosis;
- taking psychotropic medication within the last 30 days, including aripiprazole;
- known allergy to aripiprazole, or known adverse reaction to antipsychotics;
- currently using or unwilling not to use phenylephrine or ephedrine-containing products for trial duration (can cause false positive urines for methamphetamine use);
- current CD4 count \< 200 cells/mm3;
- using other medications known to interact with aripiprazole, including ketoconazole and carbamazepine;
- measured moderate or severe liver disease (AST, ALT, and total bilirubin \> 3 times normal) and/or any symptoms of current liver disease;
- impaired renal function (creatinine clearance \< 60 ml/min);
- diabetes mellitis type I or type II, including cases controlled with diet alone;
- Hypertension that is not well-controlled;
- BMI ≥ 40; or BMI ≥ 35 with more than one of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, known hyperlipidemia;
- History of, or known active cardiovascular disease including: (a) Previous myocardial infarction (heart attack); (b) angina pectoris; (c) congestive heart failure; (d) valvular heart disease including mitral valve prolapse; (e) cardiomyopathy; (f) pericarditis; (g) stroke or transient ischemic attack; (h) chest pain or shortness of breath with activity (such as walking up stairs); (i) peripheral vascular disease or risk equivalent; (j) other heart conditions under the care of a doctor;
- currently participating in another research study;
- pregnant, breast-feeding, and/or positive pregnancy test at screening or enrollment visit;
- any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco Department of Public Health, AIDS Office
San Francisco, California, 94102, United States
Related Publications (1)
Coffin PO, Santos GM, Das M, Santos DM, Huffaker S, Matheson T, Gasper J, Vittinghoff E, Colfax GN. Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial. Addiction. 2013 Apr;108(4):751-61. doi: 10.1111/add.12073. Epub 2013 Jan 3.
PMID: 23186131RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Phillip O. Coffin, Director of Substance Use Research
- Organization
- San Francisco Department of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Phillip O Coffin, MD, MIA
Director of Substance Use Research, San Francisco Department of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Substance Use Research
Study Record Dates
First Submitted
July 5, 2007
First Posted
July 6, 2007
Study Start
March 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 24, 2014
Results First Posted
March 24, 2014
Record last verified: 2014-02