| 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.
|
| 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.
|