Modafinil for Methamphetamine Dependence

NCT00859573 | Terminated Phase 2 Results DMC

• 2 other identifiers: P50 DA018197-104386P50DA018197
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

• Mean Treatment Effectiveness Scores

  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.

  thrice weekly from week 3 through week 8

Study Arms (2)

1. Modafinil

ACTIVE COMPARATOR

Drug: Modafinil

2: Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Modafinil DRUG

400 mg/day

1. Modafinil

Placebo DRUG

inactive substance

2: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Small number of completers leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Michael J. Mancino, M.D.
• Organization: University of Arkansas for Medical Sciences

mjmancino@uams.edu

501-526-8442

Study Officials

• Michael Mancino, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 21, 2017
• Results First Posted: July 15, 2011

Record last verified: 2017-10

Locations

US (1)