Methylphenidate to Treat Methamphetamine Dependence (MPH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01044238
First received: January 6, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Methamphetamine Dependence
Drug: methylphenidate
Drug: Methylphenidate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sustained-Release Methylphenidate for Management of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • percentage of methamphetamine-negative urine samples compared across two conditions [ Time Frame: 14-week study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retention: number of days retained in treatment from randomization to the last scheduled clinic visit [ Time Frame: 14 week study duration ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044238

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

No publications provided

Responsible Party: Walter Ling, PI, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01044238     History of Changes
Other Study ID Numbers: 1R01DA025084
Study First Received: January 6, 2010
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
methamphetamine
methylphenidate
clinical trial
random assignment
double blind
abstinence
reduction in methamphetamine use

Additional relevant MeSH terms:
Methamphetamine
Methylphenidate
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014