Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

NCT00218387 | Completed Phase 2 Results DMC

• 4 other identifiers: NIDA-16368-1R01DA016368R01-16368-1DPMC
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.

Conditions

Cocaine Dependence

Keywords

Cocaine Dependence

Outcome Measures

Primary Outcomes (2)

• Number of Cocaine Non-use Days

  Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.

  8 weeks

• Percent of Participants With New Use

  New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.

  8 weeks

Study Arms (3)

200mg Modafinil

EXPERIMENTAL

200mg Modafinil

Drug: Modafinil

400mg Modafinil

EXPERIMENTAL

400mg Modafinil

Drug: Modafinil

Matching Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Matching Placebo

Interventions

Modafinil DRUG

200mg Modafinil

Also known as: Provigil

200mg Modafinil

Matching Placebo DRUG

Matching Placebo

Matching 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:

• Seeking treatment for cocaine dependence
• Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
• If female, willing to use effective contraception throughout the study
• Lives within 50 miles of the research center and has reliable transportation

You may not qualify if:

• Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
• Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
• Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
• Recent suicidal or homicidal attempts within 60 days of study entry
• Suicidal or homicidal ideation within 30 days of study entry
• Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)
• Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
• Required by the court to obtain treatment for cocaine dependence
• Not seeking treatment for cocaine dependence
• Participated in cocaine treatment (clinical or research) within 30 days of study entry
• Anticipating elective surgery or hospitalization within 20 weeks of study entry
• Known or suspected hypersensitivity to modafinil
• Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants
• Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine
• Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robert Malcolm, MD
• Organization: Medical University of SC

malcomr@musc.edu

843-792-1901

Study Officials

• Robert Malcolm, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Family Medicine & Pediatrics

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 10, 2019
• Results First Posted: April 10, 2019

Record last verified: 2019-03

Locations

US (1)