Safety and Tolerability of Modafinil for Methamphetamine Dependence

NCT00569374 | Completed Phase 2 Results

• 1 other identifier: Protocol / IRB # 79045
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• "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

• 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

• 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

Secondary Outcomes (1)

• Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.

  Thrice weekly for the first three weeks

Interventions

Modafinil DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Alison Oliveto
• Organization: University of Arkansas for Medical Sciences Center for Addiction Research

olivetoalison@uams.edu

501-526-8441

Study Officials

• Dr. Janette McGaugh, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: October 5, 2010
• Results First Posted: March 22, 2010

Record last verified: 2010-09

Locations

US (1)