Clinical trial NCT00859573: Modafinil for Methamphetamine Dependence
Official title: Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Treatment Effectiveness Scores
timeFrame: thrice weekly from week 3 through week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Michael Mancino, MD
role: PRINCIPAL_INVESTIGATOR
References: