Trial · NCT00497055

Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

NCT00497055, Phase 2, Completed, San Francisco Department of Public Health; results first posted 2014-03-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals. Trials, record NCT00497055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00497055

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals
NCT number: NCT00497055
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: San Francisco Department of Public Health
Conditions: Substance Abuse, HIV Infections
Interventions: Aripiprazole, Placebo
First posted: 2007-07-06
Last updated: 2014-03-24
Results first posted: 2014-03-24

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.	Final study visit at week 12	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.
Primary	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.	Adherence as determined by MEMS (throughout study, up to 12 weeks)	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.)
Primary	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)

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.	Final study visit at week 12	perc of positive urines at final visit	NUMBER
PRIMARY	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.	Adherence as determined by MEMS (throughout study, up to 12 weeks)	percent adherence from MEMS	MEAN
PRIMARY	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)	total reported adverse events	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.	Aripiprazole	44		perc of positive urines at final visit
To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.	Placebo	40		perc of positive urines at final visit
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.	Aripiprazole	46	Standard Deviation 32	percent adherence from MEMS
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.	Placebo	39	Standard Deviation 27	percent adherence from MEMS
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.	Aripiprazole	156		total reported adverse events
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.	Placebo	144		total reported adverse events

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aripiprazole	45
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Aripiprazole	35
Overall Study	COMPLETED	Placebo	40
Overall Study	NOT COMPLETED	Aripiprazole	10
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events62

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abrasions	Skin and subcutaneous tissue disorders	Aripiprazole	3	45
other	Abrasions	Skin and subcutaneous tissue disorders	Placebo	1	45
other	Akathisia	Nervous system disorders	Aripiprazole	12	45
other	Akathisia	Nervous system disorders	Placebo	2	45
other	Abscess	Skin and subcutaneous tissue disorders	Aripiprazole	1	45
other	Abscess	Skin and subcutaneous tissue disorders	Placebo	4	45
other	Contusion	Skin and subcutaneous tissue disorders	Aripiprazole	1	45
other	Contusion	Skin and subcutaneous tissue disorders	Placebo	4	45
other	Drowsiness	General disorders	Aripiprazole	6	45
other	Drowsiness	General disorders	Placebo	0	45

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aripiprazole
Total, all-cause mortality	Placebo
Total, other adverse events	Aripiprazole	35	45
Total, other adverse events	Placebo	36	45
Total, serious adverse events	Aripiprazole	3	45
Total, serious adverse events	Placebo	4	45

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23186131	RESULT

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01DA023387	Aripiprazole to reduce methamphetamine use among MSM with high-risk HIV behaviors	COFFIN, PHILLIP O	PUBLIC HEALTH FOUNDATION ENTERPRISES	NATIONAL INSTITUTE ON DRUG ABUSE	2007 to 2011	NIH RePORTER
R01DA022190	Aripiprazole Treatment for Methamphetamine Dependence Among High-Risk MSM	COLFAX, GRANT NASH	PUBLIC HEALTH FOUNDATION ENTERPRISES	NATIONAL INSTITUTE ON DRUG ABUSE	2006 to 2008	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Aripiprazole vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00497055

GET https://conductscience.org/api/trials/v1/NCT00497055/events?page=2

API reference For AI assistants