AcampMet: A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00571922
• Collaborator: Forest Laboratories (Industry)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence, Treatment Seeking	Drug: Acamprosate; Drug: placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acamprosate	Drug: Acamprosate; 2 gr/day (333 mg, TID); Other Names: Campral
Placebo Comparator: Placebo	Drug: placebo; matching placebo

Outcome Measures

Primary Outcome Measures

1. Methamphetamine Abstinence [7 day]

Secondary Outcome Measures

1. Craving [7 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Methamphetamine dependence

• Treatment seeking

• Urine sample (+) for methamphetamine

Exclusion Criteria:

• Pregnancy

• Dependence on other drugs (except nicotine)

• DSM-IV axis I disorder unrelated to drug abuse

• Serious medical condition in clinicians opinion.

• AIDs

• Untreated syphilis

• Allergy to acamprosate

• Methadone, or other ORP, maintenance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA New York Harbor Healthcare System, MHAD clinic	New York	New York	United States	10010

Sponsors and Collaborators

• NYU Langone Health
• Forest Laboratories

Investigators

• Principal Investigator: Malcolm Reid, PhD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00571922
• Other Study ID Numbers: 06-632
• First Posted: Dec 12, 2007
• Last Update Posted: Mar 24, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by NYU Langone Health: methamphetamine, crystal, treatment
• Additional relevant MeSH terms: Acamprosate

Study Results

Participant Flow

Arm/Group Title	Acamprosate	Placebo
Arm/Group Description	Acamprosate: 2 gr/day (333 mg, TID)	placebo: matching placebo
Period Title: Overall Study
STARTED	36	36
COMPLETED	0	0
NOT COMPLETED	36	36

Baseline Characteristics

Arm/Group Title	Acamprosate	Placebo	Total
Arm/Group Description	Acamprosate: 2 gr/day (333 mg, TID)	placebo: matching placebo	Total of all reporting groups
Overall Participants	36	36	72
Age (Count of Participants)
<=18 years	NA NaN	NA NaN	NA NaN
Between 18 and 65 years	NA NaN	NA NaN	NA NaN
>=65 years	NA NaN	NA NaN	NA NaN
Sex: Female, Male (Count of Participants)
Female	NA NaN	NA NaN	NA NaN
Male	NA NaN	NA NaN	NA NaN

Outcome Measures

1. Primary Outcome

Title	Methamphetamine Abstinence
Time Frame	7 day

Outcome Measure Data

Analysis Population Description

PI passed away, data is unavailable.

Arm/Group Title	Acamprosate	Placebo
Arm/Group Description	Acamprosate: 2 gr/day (333 mg, TID)	placebo: matching placebo
Measure Participants	0	0

2. Secondary Outcome

Title	Craving
Time Frame	7 day

Outcome Measure Data

Analysis Population Description

PI passed away, data is unavailable

Arm/Group Title	Acamprosate	Placebo
Arm/Group Description	Acamprosate: 2 gr/day (333 mg, TID)	placebo: matching placebo
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	PI passed away, and there is no access to data. Information regarding adverse and serious adverse events is unavailable.
Arm/Group Title	Acamprosate		Placebo
Arm/Group Description	Acamprosate: 2 gr/day (333 mg, TID)		placebo: matching placebo
All Cause Mortality
	Acamprosate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Acamprosate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Acamprosate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Sadly, the PI of this study passed away on 4/20/2010. Data was not analyzed and is unavailable.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.