Modafinil for Methamphetamine Dependence - Full Text View

Purpose

Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: Modafinil Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Amphetamine Methamphetamine Modafinil Armodafinil

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Mean Treatment Effectiveness Scores [ Time Frame: thrice weekly from week 3 through week 8 ] [ Designated as safety issue: No ]
Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.
Withdrawal Symptoms [ Time Frame: thrice weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pre-attentional Neurophysiological Measures [ Time Frame: week 0, week 2, week 10 ] [ Designated as safety issue: No ]
Attentional Neurophysiological Measures [ Time Frame: week 0, 2, 10 ] [ Designated as safety issue: No ]
Vital Signs [ Time Frame: thrice weekly ] [ Designated as safety issue: Yes ]

Enrollment:	9
Study Start Date:	April 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1. Modafinil	Drug: Modafinil 400 mg/day
Placebo Comparator: 2: Placebo Placebo	Drug: Placebo inactive substance

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859573

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Michael Mancino, MD

University of Arkansas

More Information

No publications provided

Responsible Party:	Michael Mancino, MD/Assistant Professor, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier:	NCT00859573 History of Changes
Other Study ID Numbers:	P50 DA018197-104386, P50 DA018197, DPMCDA
Study First Received:	March 10, 2009
Results First Received:	April 15, 2011
Last Updated:	June 17, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Methamphetamine
Amphetamine
Modafinil
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013