Safety and Tolerability of Modafinil for Methamphetamine Dependence

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Heart Rate	Thrice weekly for 7 weeks	Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.
Systolic Blood Pressure	Thrice weekly for 7 weeks	Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Diastolic Blood Pressure	Thrice weekly for 7 weeks	Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
"Modafinil Side Effects Checklist"	Weekly for 7 weeks	Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from "not at all" (0) to "very much (4). The score was determined by units on a scale.
Anxiety as Measured by the Hamilton Anxiety Scale	Thrice weekly for 7 weeks	Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.
Depression as Measured by the Hamilton Depression Scale	Thrice weekly for 7 weeks	Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.

Secondary Outcome Measures

Name	Time	Method
Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.	Thrice weekly for the first three weeks	The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.