Effects of Modafinil in Methamphetamine Dependence

NCT00751023 | Completed Phase 4 Results

• 1 other identifier: HR#18440
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine; Modafinil; Addiction; Craving; Cognitive

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Methamphetamine-positive Urine Drug Screens

  Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5)

  5 weeks

Secondary Outcomes (7)

• Percent Change in California Verbal Learning Test From Baseline to Study Endpoint

  Study baseline to study endpoint (Week 5)

• Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint

  5 Weeks

• Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint

  5 weeks

• Score on the Wisconsin Card Sort Test

  5 weeks

• Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint

  5 weeks

Study Arms (2)

1

EXPERIMENTAL

Modafinil 400 mg daily

Drug: Modafinil

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Modafinil DRUG

400 mg daily for four weeks

Also known as: Provigil

1

Placebo DRUG

Placebo 2 tablets daily for 4 weeks

2

Eligibility Criteria

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

You may qualify if:

• Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
• Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
• Subjects must consent to random assignment to the modafinil vs. placebo conditions.

You may not qualify if:

• Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
• Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
• Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
• Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
• Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
• Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
• Known or suspected hypersensitivity to modafinil.
• Individuals taking medications that could adversely interact with study medications.
• Subjects with a history of epilepsy or seizure disorder.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Limited sample size (n=40, n=20 in each group), relatively low retention (55% overall; 45% in modafinil group, 65% in placebo group)

Results Point of Contact

• Title: Bryan K. Tolliver, MD PhD
• Organization: Medical University of South Carolina

tollive@musc.edu

843-792-4869

Study Officials

• Bryan K Tolliver, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: September 10, 2008
• First Posted: September 11, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-05

Locations

US (1)