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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00218387
First received: September 16, 2005
Last updated: November 7, 2011
Last verified: September 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: CBT and Modafinil for Cocaine Addiction

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

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 ]

Enrollment: 326
Study Start Date: April 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
200mg Modafinil
Drug: Modafinil
200mg Modafinil
Other Name: Provigil
Experimental: 2
400mg Modafinil
Drug: Modafinil
400mg Modafinil
Other Name: Provigil
Placebo Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Robert Malcolm, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Robert Malcolm, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00218387     History of Changes
Other Study ID Numbers: NIDA-16368-1, R01DA016368, R01-16368-1, DPMC
Study First Received: September 16, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014