| March 10, 2009 |
| March 10, 2009 |
| March 2009 |
- urine toxicology screens [ Time Frame: thrice weekly ] [ Designated as safety issue: No ]
- withdrawal symptoms [ Time Frame: thrice weekly ] [ Designated as safety issue: No ]
|
| Same as current |
| No Changes Posted |
- pre-attentional neurophysiological measures [ Time Frame: week 0, week 2, week 10 ] [ Designated as safety issue: No ]
- attentional neurophysiological measures [ Time Frame: week 0, 2, 10 ] [ Designated as safety issue: No ]
- vital signs [ Time Frame: thrice weekly ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Modafinil for Methamphetamine Dependence |
| Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers |
Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Methamphetamine Dependence |
- Drug: Modafinil
- Drug: Placebo
|
| Placebo Comparator: Placebo |
| |
| |
| Not yet recruiting |
| 50 |
| March 2010 |
| March 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).
- not currently enrolled in a treatment program
- subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
- subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
- women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study.
Exclusion Criteria:
- current diagnosis of alcohol, opiate, or sedative physical dependence
- ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
- history of schizophrenia, or bipolar type I disorder
- present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
- medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine or desipramine)
- current suicidality or psychosis
- Liver function tests (i.e., liver enzymes) greater than three times normal levels
- pregnancy or breastfeeding
|
| Both |
| 18 Years to 65 Years |
| No |
|
|
|
|
| |
| NCT00859573 |
| Michael Mancino, MD/Assistant Professor, University of Arkansas for Medical Sciences |
| P50 DA018197 |
| National Institute on Drug Abuse (NIDA) |
| University of Arkansas |
| Principal Investigator: |
Michael Mancino, MD |
University of Arkansas |
|
|
| National Institute on Drug Abuse (NIDA) |
| March 2009 |
