Methylphenidate to Treat Methamphetamine Dependence (MPH)

• ClinicalTrials.gov Identifier: NCT01044238
• Recruitment Status: Unknown
• First Posted: January 7, 2010
• Last Update Posted: May 20, 2014
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Walter Ling, University of California, Los Angeles

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 (Clinical Trial)
• Estimated 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: October 2010
• Estimated Primary Completion Date: July 2014
• Estimated Study Completion Date: July 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 Name: 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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. percentage of methamphetamine-negative urine samples compared across two conditions [ Time Frame: 14-week study duration ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Be seeking treatment for their MA use disorder;
2. Be between 18-55 years of age;
3. Meet DSM-IV-TR criteria for MA dependence as assessed by the Mini International Neuropsychological Interview (MINI);

Exclusion Criteria:

1. Have any history or evidence suggestive of seizures or brain injury;
2. Have any known hypersensitivity or previous medically adverse reaction to methylphenidate;
3. 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;
4. 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.
5. Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by medical history;
6. Have evidence of an untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV);
7. Have clinically significant abnormal vital signs;
8. 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)];
9. Have a baseline ECG that demonstrates clinically significant abnormalities;
10. Have known preexisting severe gastrointestinal narrowing,
11. 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);
12. A history of glaucoma;
13. 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;
14. Have any other medical condition that would, in the opinion of the study physician, make participation difficult or unsafe.

Contacts and Locations

Locations

United States, California

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

More Information

• Responsible Party: Walter Ling, PI, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01044238
• Other Study ID Numbers: 1R01DA025084 ( U.S. NIH Grant/Contract )
• First Posted: January 7, 2010
• Last Update Posted: May 20, 2014
• Last Verified: May 2014

Keywords provided by Walter Ling, University of California, Los Angeles:

methamphetamine; methylphenidate; clinical trial; random assignment; double blind; abstinence; reduction in methamphetamine use

Additional relevant MeSH terms:

Methylphenidate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents