Substance AbusePhase 2NCT00497055

Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

A Phase 2 study testing Aripiprazole in people with Substance Abuse and HIV Infections, run by San Francisco Department of Public Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Substance Abuse, HIV Infections
What is being tested?: Aripiprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Mar 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco Department of Public Health, AIDS Office
San Francisco, California, 94102

Other trials in United States

About this study

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.

Read the detailed description

Population-based surveys estimate that the prevalence of methamphetamine use is 20 times higher among men who have sex with men (MSM) compared to the general population. Methamphetamine-associated sexual risk behavior is also a driving force in the MSM HIV epidemic: methamphetamine use has been associated with increased number of sexual partners, unprotected sex acts, sexually transmitted infections (STIs), and HIV acquisition. Despite these alarming data, relatively few interventions have been tested among methamphetamine-using MSM. Among heterosexual non-injection drug users, methamphetamine use has been associated with well characterized risks for HIV and STDs including increased numbers of sexual partners, less condom use than non-methamphetamine users, engaging in sex work, and self-reported history of STDs. In parallel with the continued testing of behavioral approaches, we believe the time has come to test the feasibility and acceptability of pharmacologic interventions to reduce methamphetamine use among high-risk individuals. Pharmacologic approaches to treating substance use have been successful in treating nicotine, alcohol, and heroin dependencies. Preliminary dosing studies demonstrate that aripiprazole (Abilify), an FDA-approved, well-tolerated antipsychotic and partial dopamine agonist, reduced the effects of methamphetamine in humans and exhibited a good safety profile. We propose to expand upon these promising results by conducting a randomized, double-blind, placebo-controlled pilot study of aripiprazole among sexually-active, methamphetamine-dependent individuals.

The specific aims of this study are:

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-negative urines and by self-report of methamphetamine use in the aripiprazole versus placebo group.
To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps and self-report) medication adherence to aripiprazole and placebo.
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.

If promising, study results will be used to design larger, definitive clinical trials to determine the efficacy of aripiprazole in reducing methamphetamine use and corresponding methamphetamine-associated sexual risk among MSM. This pilot study is therefore designed to reflect the structure of such trials. We will enroll 90 sexually active, methamphetamine-dependent individuals who will be randomized 1:1 to receive aripiprazole (n=45) or placebo (n=45) for 12 weeks. Because we are testing a drug for a new indication in a new population, we will include extensive safety parameters, as done in prior studies of pharmacologic interventions among substance users. We will also include both urine testing and extensive behavioral risk assessments because we anticipate that future definitive efficacy trials will analyze both substance use and sexual risk behavior outcomes. Study participants will be seen at the San Francisco Department of Public Health AIDS Office where they will provide urines for drug testing and participate in substance use counseling. All participants will receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures via audio computer-assisted self-interview (ACASI).

Conditions: Substance Abuse, HIV Infections
Being tested: Aripiprazole, Placebo
Keywords: Methamphetamine, HIV, MSM, HIV Seronegativity
Medical subject headings: Substance-Related Disorders, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AripiprazoleDrug
Also called Abilify
PlaceboDrug
Sugar pill manufactured to mimic Aripiprazole gel caps.

Study groups in NCT00497055
Study group	Role	What they receive
Aripiprazole	Experimental	Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve. Receives: Drug: Aripiprazole
Placebo	Placebo comparator	Placebo (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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.)
Measured: 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.
Measured: Total reported adverse events (throughout study, up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Mar 2012

First posted6 Jul 2007 (estimated)
Study startMar 2009
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Substance AbuseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00497055
Sponsor's protocol ID: 1R01DA022190-01
Other IDs: 1R01DA022190-01, 1R01DA023387-01, DPMC
Status last verified: Feb 2014
First submitted: 5 Jul 2007
Last updated: 24 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23186131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals
ClinicalTrials.gov ID: NCT00497055
Acronym / sponsor ID: 1R01DA022190-01
Conditions: Substance Abuse, HIV Infections
Keywords: Methamphetamine, HIV, MSM, HIV Seronegativity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: San Francisco Department of Public HealthOther government
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Mar 2009
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 6 Jul 2007 (estimated)
Results: Posted 24 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific aims of this study are:

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-negative urines and by self-report of methamphetamine use in the aripiprazole versus placebo group.
To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps and self-report) medication adherence to aripiprazole and placebo.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aripiprazole	Experimental	Drug: AripiprazoleAripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
Placebo	Placebo comparator	Drug: PlaceboPlacebo (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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AripiprazoleAlso: Abilify	Drug	Aripiprazole
PlaceboSugar pill manufactured to mimic Aripiprazole gel caps.	Drug	Placebo

Primary outcome

To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.
Time frame: 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.
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.
Time frame: 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.)
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.
Time frame: Total reported adverse events (throughout study, up to 12 weeks)

Results and safety

Results posted to the registry on 24 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole	45	35
Placebo	45	40

Primary outcome: To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.

Time frame: Final study visit at week 12. Number. Unit: perc of positive urines at final visit

Measure	Aripiprazole n = 45	Placebo n = 45
Value	44	40

Aripiprazole vs Placebo: Risk Ratio (RR): .88 (95% CI .66 to 1.16), p = .41, Generalized estimating equation

Primary outcome: 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.

Time frame: Adherence as determined by MEMS (throughout study, up to 12 weeks). Mean (Standard Deviation). Unit: percent adherence from MEMS

Measure	Aripiprazole n = 45	Placebo n = 45
Value	46 (32)	39 (27)

Aripiprazole vs Placebo: p = 0.31, Wilcoxon (Mann-Whitney)

Primary outcome: 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.

Time frame: Total reported adverse events (throughout study, up to 12 weeks). Number. Unit: total reported adverse events

Measure	Aripiprazole n = 45	Placebo n = 45
Value	156	144

Aripiprazole vs Placebo: p >=0.99, Fisher Exact

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole	3 of 45 (6.7%)	35 of 45 (77.8%)	Not reported
Placebo	4 of 45 (8.9%)	36 of 45 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23186131Coffin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Phillip O Coffin, MD, MIA principal investigator

Director of Substance Use Research, San Francisco Department of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aripiprazole in people with Substance Abuse and HIV Infections, run by San Francisco Department of Public Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals. (time frame: Final study visit at week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00497055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.