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

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218387

Purpose

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.

Condition	Intervention	Phase
Cocaine Dependence	Drug: Modafinil Drug: Matching Placebo	Phase II

Drug Information available for: Modafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	CBT and Modafinil for Cocaine Addiction

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

1) Number of cocaine non-use days and 2) Consecutive cocaine non-use days [ Time Frame: April 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	309
Study Start Date:	April 2004
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 200mg Modafinil	Drug: Modafinil 200mg Modafinil
2: Experimental 400mg Modafinil	Drug: Modafinil 400mg Modafinil
3: Placebo Comparator Matching Placebo	Drug: Matching Placebo Matching Placebo

Detailed Description:

The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness.

Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.

A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests.

Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion criteria:

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
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218387

Contacts

Contact: Kristi Huebner, MPH

(843)792-1901

huebnerk@musc.edu

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kristi Huebner, MPH 843-792-1901 huebnerk@musc.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Robert Malcolm, MD

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Robert Malcolm, MD )
Study ID Numbers:	NIDA-16368-1, R01-16368-1, DPMC
Study First Received:	September 16, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00218387 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Behavior, Addictive
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Central Nervous System Stimulants
Cocaine
Neuroprotective Agents
Modafinil

Additional relevant MeSH terms:

Cocaine-Related Disorders
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Substance-Related Disorders
Disorders of Environmental Origin

Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Modafinil

ClinicalTrials.gov processed this record on May 07, 2009