MPH: Methylphenidate to Treat Methamphetamine Dependence

Sponsor

University of California, Los Angeles (Other)

Overall Status

Unknown status

CT.gov ID

NCT01044238

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Drug: methylphenidate Drug: Methylphenidate	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Sustained-Release Methylphenidate for Management of Methamphetamine Dependence

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

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	Drug: methylphenidate 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: Concerta
Placebo Comparator: Placebo Condition randomly assigned to receive placebo, provided to appear identical to active medication	Drug: Methylphenidate 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: Placebo

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

Drug: methylphenidate

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:

Concerta

Placebo Comparator: Placebo

Condition randomly assigned to receive placebo, provided to appear identical to active medication

Drug: Methylphenidate

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:

Placebo

Outcome Measures

Primary Outcome Measures

percentage of methamphetamine-negative urine samples compared across two conditions [14-week study duration]

Secondary Outcome Measures

Retention: number of days retained in treatment from randomization to the last scheduled clinic visit [14 week study duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center	Los Angeles	California	United States	90025

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator: Walter Ling, M.D., UCLA Integrated Substance Abuse Programs
Study Director: Maureen Hillhouse, Ph.D., UCLA Integrated Substance Abuse Programs