Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

NCT ID: NCT00520286

Last Updated: 2017-04-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Methamphetamine Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modafinil

Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type DRUG

200 mg or 400 mg /daily

Placebo

Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo / daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modafinil

200 mg or 400 mg /daily

Intervention Type DRUG

Placebo

Placebo / daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must be between the ages of 18 and 65
* Methamphetamine dependent as defined by DSM-IV criteria
* Must be in good general heath with a history of methamphetamine use at screening
* Must be able to provide written informed consent
* If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria

* Please contact site for more information
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Elkashef, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

South Bay Treatment Center

San Diego, California, United States

Site Status

Matrix Institute on Addictions

Tarzana, California, United States

Site Status

Torrance Site

Torrance, California, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

John A. Burns School of Medicine

Honolulu, Hawaii, United States

Site Status

Powell Chemical Dependency Center

Des Moines, Iowa, United States

Site Status

START Research and Treatment

Kansas City, Missouri, United States

Site Status

Salt Lake City VA Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12.

Reference Type RESULT
PMID: 21840138 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIDA-CSP-1026-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Modafinil for Methamphetamine Dependence
NCT00859573 TERMINATED PHASE2
Studying Amphetamine Withdrawal in Humans
NCT01215929 COMPLETED PHASE2