- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044238
Methylphenidate to Treat Methamphetamine Dependence (MPH)
May 19, 2014 updated by: Walter Ling, University of California, Los Angeles
Sustained-Release Methylphenidate for Management of Methamphetamine Dependence
This 4-year study will investigate the effectiveness of methylphenidate for initiating and sustaining abstinence in methamphetamine dependent individuals.
Approximately 90 participants seeking treatment for methamphetamine dependence will be enrolled in the study for an initial 2 weeks to establish clinic compliance.
During this compliance phase, participants will receive incentives for clinic attendance.
After meeting clinic attendance requirements, participants will be randomized to placebo (n = 45) or active study medication (n = 45) conditions, and given 18mg/daily of study drug or placebo for one week, followed by 36mg/daily study drug/placebo for a second week.
Finally, participants will be stabilized on 54mg/daily study drug/placebo for the remainder of the study.
Placebo participants will be given placebo medications prepared to appear identical to the active medication.
In addition, after randomization, all participants will receive motivational incentives for methamphetamine-negative urine tests and begin weekly cognitive behavioral therapy (CBT) provided for the duration of the study.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90025
- UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be seeking treatment for their MA use disorder;
- Be between 18-55 years of age;
- Meet DSM-IV-TR criteria for MA dependence as assessed by the Mini International Neuropsychological Interview (MINI);
Exclusion Criteria:
- Have any history or evidence suggestive of seizures or brain injury;
- Have any known hypersensitivity or previous medically adverse reaction to methylphenidate;
- Have a neurological or psychiatric disorder, such as psychosis, bipolar illness, motor tics, Tourette's syndrome, or major depression; organic brain disease or dementia; marked anxiety, tension and agitation; or any psychiatric disorder that would require ongoing treatment or that would make study compliance difficult;
- Have evidence of clinically significant heart disease or hypertension as determined by medical history or physical examination, including pre-existing heart failure, recent myocardial infarction, ventricular arrhythmia, cardiomyopathy, serious heart rhythm abnormalities, and coronary artery disease.
- Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by medical history;
- Have evidence of an untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV);
- Have clinically significant abnormal vital signs;
- Have clinically significant abnormal hematology or chemistry laboratory tests [e.g. liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase), kidney function tests (creatinine and BUN)];
- Have a baseline ECG that demonstrates clinically significant abnormalities;
- Have known preexisting severe gastrointestinal narrowing,
- Be pregnant or nursing. Females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or use a reliable form of contraception including hormonal (oral, Depo-Provera or Nuva-ring), intra-uterine devise, sterilization or double barrier method (simultaneous use of two barrier methods such as condom, diaphragm, spermicide);
- A history of glaucoma;
- Use of some medications such as Clonidine, coumarin anticoagulants, anticonvulsants (Phenobarbital, phenytoin, primidone), vasopressor agents, and some antidepressants (tricyclics and selective serotonin reuptake inhibitors),. Also, current use of an MAO inhibitor, or use within 14 days of enrollment;
- Have any other medical condition that would, in the opinion of the study physician, make participation difficult or unsafe.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: active medication (methylphenidate)
Condition receiving active medication: 18mg/day during week 1; 36mg/day during week 2; 54mg/day during remainder of study
|
18mg/day in week 1; 36mg/day in week 2; 54mg/day in week 3 - participants randomized to either active medication (methylphenidate) or placebo matched to active drug
Other Names:
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Placebo Comparator: Placebo
Condition randomly assigned to receive placebo, provided to appear identical to active medication
|
18mg/day for week 1; 36mg/day for week 2; 54mg/day for remainder of study - participants randomized to either active medication (methylphenidate) or placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of methamphetamine-negative urine samples compared across two conditions
Time Frame: 14-week study duration
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14-week study duration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retention: number of days retained in treatment from randomization to the last scheduled clinic visit
Time Frame: 14 week study duration
|
14 week study duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Maureen Hillhouse, Ph.D., UCLA Integrated Substance Abuse Programs
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
January 6, 2010
First Submitted That Met QC Criteria
January 6, 2010
First Posted (Estimate)
January 7, 2010
Study Record Updates
Last Update Posted (Estimate)
May 20, 2014
Last Update Submitted That Met QC Criteria
May 19, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA025084 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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