Safety and Tolerability of Modafinil for Methamphetamine Dependence
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|ClinicalTrials.gov Identifier: NCT00569374|
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : March 22, 2010
Last Update Posted : October 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence||Drug: Modafinil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Tolerability of Modafinil for Methamphetamine Dependence|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2008|
- Drug: Modafinil
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
- Heart Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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" [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569374
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Dr. Janette McGaugh, MD||University of Arkansas|