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

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Modafinil
Matching Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

200mg Modafinil

400mg Modafinil

Matching Placebo

Arm Description

200mg Modafinil

400mg Modafinil

Matching Placebo

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
March 20, 2019
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218387
Brief Title
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Official Title
CBT and Modafinil for Cocaine Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200mg Modafinil
Arm Type
Experimental
Arm Description
200mg Modafinil
Arm Title
400mg Modafinil
Arm Type
Experimental
Arm Description
400mg Modafinil
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
200mg Modafinil
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
400mg Modafinil
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Number of Cocaine Non-use Days
Description
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Time Frame
8 weeks
Title
Percent of Participants With New Use
Description
New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Malcolm, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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

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