Methylphenidate to Treat Methamphetamine Dependence (MPH)
Sustained-Release Methylphenidate for Management of Methamphetamine Dependence
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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:
|
|
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
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
percentage of methamphetamine-negative urine samples compared across two conditions
Time Frame: 14-week study duration
|
14-week study duration
|
Secondary Outcome Measures
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
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Maureen Hillhouse, Ph.D., UCLA Integrated Substance Abuse Programs
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
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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