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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Heart Rate
Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.
Time frame: Thrice weekly for 7 weeks
Systolic Blood Pressure
Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Time frame: Thrice weekly for 7 weeks
Diastolic Blood Pressure
Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Time frame: Thrice weekly for 7 weeks
"Modafinil Side Effects Checklist"
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.
Time frame: Weekly for 7 weeks
Anxiety as Measured by the Hamilton Anxiety Scale
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.
Time frame: Thrice weekly for 7 weeks
Depression as Measured by the Hamilton Depression Scale
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.
Time frame: Thrice weekly for 7 weeks
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Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.
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.
Time frame: Thrice weekly for the first three weeks