Phase 2
Completed N=8
Safety and Tolerability of Modafinil for Methamphetamine Dependence
Methamphetamine Dependence
Source: ClinicalTrials.gov NCT00569374 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Heart Rate — 79.66 beats per minute
Summary
This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate |
79.66 | — |
| PRIMARY Systolic Blood Pressure |
128.62 | — |
| PRIMARY Diastolic Blood Pressure |
81.49 | — |
| PRIMARY "Modafinil Side Effects Checklist" |
3.75 | — |
| PRIMARY Anxiety as Measured by the Hamilton Anxiety Scale |
4.07 | — |
| PRIMARY Depression as Measured by the Hamilton Depression Scale |
5.64 | — |
| SECONDARY Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire. |
5.79 | — |
Eligibility Criteria
Inclusion Criteria
- 18-65 years old
- 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
Data sourced from ClinicalTrials.gov (NCT00569374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.