Status:
COMPLETED
Effects of Modafinil in Methamphetamine Dependence
Lead Sponsor:
Medical University of South Carolina
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated wi...
Eligibility Criteria
Inclusion
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
- Subjects must consent to random assignment to the modafinil vs. placebo conditions.
Exclusion
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
- Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
- Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
- Known or suspected hypersensitivity to modafinil.
- Individuals taking medications that could adversely interact with study medications.
- Subjects with a history of epilepsy or seizure disorder.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00751023
Start Date
February 1 2009
End Date
July 1 2010
Last Update
June 13 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671