Safety and Tolerability of Modafinil for Methamphetamine Dependence

Methamphetamine Dependence Clinical Trial

Official title:

Safety and Tolerability of Modafinil for Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569374
• Other study ID #: Protocol / IRB # 79045
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: September 30, 2010
• Start date: September 2007

Study information

• Verified date: September 2010
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.	Thrice weekly for 7 weeks	Yes
Primary	Systolic Blood Pressure	Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.	Thrice weekly for 7 weeks	Yes
Primary	Diastolic Blood Pressure	Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.	Thrice weekly for 7 weeks	Yes
Primary	"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.	Weekly for 7 weeks	Yes
Primary	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.	Thrice weekly for 7 weeks	Yes
Primary	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.	Thrice weekly for 7 weeks	Yes
Secondary	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.	Thrice weekly for the first three weeks	No