Status:
COMPLETED
Modafinil vs Placebo for the Treatment of Methamphetamine Dependence
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise mechanism of action...
Detailed Description
This application proposes a placebo-controlled double-blind trial of modafinil, on a platform of contingency management (CM) and individual cognitive-behavioral counseling (CBT once weekly individual ...
Eligibility Criteria
Inclusion
- 18 years of age or older;
- meet DSM-IV criteria for methamphetamine dependence;
- willing and able to comply with study procedures;
- willing and able to provide written informed consent;
- if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial and for one month after discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraceptives both during administration and for one month after discontinuation).
Exclusion
- have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes, or elevated liver enzymes (SGOT or SGPT) greater than 4 times the upper limit of normal);
- have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia or bipolar illness) as assessed by the SCID and a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID and the BDI-II;
- currently on prescription medication that is known to interact with the study drug;
- have current dependence on cocaine, opiates, alcohol, or benzodiazepines, as defined by DSM-IV-TR criteria;
- have a history of alcohol dependence within the past three years;
- have a history of mitral valve prolapse, left ventricular hypertrophy, cardiac arrhythmias, angina, myocardial infarction, acute coronary syndrome (unstable angina), cardiac syncope or presyncope, or any EKG abnormalities that suggests the presence of one of these conditions;
- have a systolic blood pressure greater than 160, a diastolic blood pressure greater than 100 (i.e. cutoffs for stage 2 hypertension), and a heart rate greater than 70% of the maximum heart rate expected for their age (0.70(220-age)) at any of the study visits.
- any other circumstances that, in the opinion of the investigators, would compromise participant safety;
- have a history of sensitivity to modafinil.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00469508
Start Date
April 1 2007
End Date
January 1 2009
Last Update
March 2 2020
Active Locations (1)
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1
UCLA Vine Street Clinic
Hollywood, California, United States, 90038