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A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Modafinil
Cognitive Behavioral Therapy--Relapse Prevention
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets DSM IV criteria for current cocaine dependence and is seeking treatment. Used cocaine at least eight days in the past month or reports episodic binges of large amounts of cocaine (at least $150 worth) at least twice per month Able to give informed consent and comply with study procedures. Exclusion Criteria: Meets DSM IV criteria for current mood disorder or past or current mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Baseline 21 item Hamilton Depression Scale scores ≥ 15 History of seizures Chronic organic mental disorder. Significant current suicidal risk. Pregnancy, lactation, or failure in sexually active female participants to use adequate contraceptive methods. Unstable physical disorders, which might make participation hazardous such as hypertension, hepatitis, participants with mildly elevated AST and ALT levels (< 3 X upper limit or normal are acceptable), or diabetes. Coronary vascular disease as indicated by history, or suspected by abnormal EKG or history of cardiac symptoms. Current use of prescribed psychotropic medications. Current use of medications that interact with modafinil: Tricyclic anti-depressants; MOA Inhibitors; diazepam; phenytoin and medications containing Ethinyl Estradiol Known hypersensitivity to modafinil Currently meets DSM-IV criteria for narcolepsy Currently meets DSM-IV criteria for ADHD Currently meets DSM-IV criteria for opioid or sedative-hypnotic dependence. Currently meets criteria for DSM-IV alcohol dependence with evidence of clinically significant physiological dependence in need of medically supervised detoxification. Current cannabis dependence is identified as the main problem-i.e. participants with current DSM-IV cannabis dependence are eligible, as long as cocaine is identified by the participant as the primary substance problem for which they are seeking treatment. Gross visual or auditory impairments First language is not English and received NO formal education in English-speaking school

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Modafinil

    Arm Description

    Placebo, was matched to modafinil up to 400 mg/day. Patients also receive motivational interviewing and Cognitive Behavioral Therapy-Relapse Prevention (CBT-RP)

    Modafinil (Active comparator). Patients received motivational interviewing and Cognitive Behavioral Therapy--relapse prevention (CBT-RP)

    Outcomes

    Primary Outcome Measures

    Cocaine use outcome at week 12 (measured with urine toxicology and self-reports)

    Secondary Outcome Measures

    Cognitive functioning at week 12 (measured with neuropsychological assessment)
    Cocaine withdrawal symptoms throughout (measured with clinical assessments and self-reports)

    Full Information

    First Posted
    June 26, 2006
    Last Updated
    November 30, 2012
    Sponsor
    Research Foundation for Mental Hygiene, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00344565
    Brief Title
    A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
    Official Title
    Combined Treatment of Modafinil and Cognitive Behavioral Therapy for Cocaine Dependence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Research Foundation for Mental Hygiene, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to test whether a cognitive behavioral therapy (CBT) and a medication called modafinil, which is approved to treat sleep disorders, will help individuals who are abusing cocaine.
    Detailed Description
    Chronic cocaine abuse has been documented to produce cognitive impairments in various domains. The observed cognitive deficits in the substance abuse population include, but are not restricted to, attention, concentration, verbal and nonverbal memory, problem solving and abstract reasoning. Our recent studies (IRB Protocol # 3998) demonstrated that in cocaine dependent participants such cognitive deficits have been shown to: 1) negatively effect retention and 2) impede the ability of the drug abuser to benefit from cognitive behavioral therapy- relapse prevention (CBT-RP) that requires participant to attend to novel stimuli, integrate new information with existing stores, and translate information into behavior change (Aharonovich, Hasin & Nunes, 2003; Aharonovich et al, in press). Furthermore, the toxic effects of cocaine together with withdrawal symptoms, such as fatigue and hypersomnia make it difficult to fully engage in any psychosocial intervention including CBT-RP. Recent findings indicate that cocaine dysregulates reward-related glutamate pathways (Dackis & O'Brien, 2003; Kalivas et al, 2003). Modafinil is a medication known to improve attention, increase wakefulness, energy, and alertness in part by increasing glutamate levels. In light of this work and the negative affect of cognitive impairments on treatment outcomes, testing cognitive enhancing medications that act on glutamate pathways is a novel promising strategy for improving treatment for cocaine dependence. Modafinil is approved for sleep disorders and is a relatively safe medication for cocaine-dependent participants as it has a low abuse potential and has shown promise in a double blind placebo controlled trial for cocaine dependence (Rush et al, 2002; Jasinski, 2000, Dackis et al, 2005). We therefore propose a double blind placebo controlled 12-week exploratory pilot study of modafinil, a "wakefulness agent," in conjunction with sessions of CBT-RP enhanced with motivational interviewing components.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, was matched to modafinil up to 400 mg/day. Patients also receive motivational interviewing and Cognitive Behavioral Therapy-Relapse Prevention (CBT-RP)
    Arm Title
    Modafinil
    Arm Type
    Active Comparator
    Arm Description
    Modafinil (Active comparator). Patients received motivational interviewing and Cognitive Behavioral Therapy--relapse prevention (CBT-RP)
    Intervention Type
    Drug
    Intervention Name(s)
    Modafinil
    Other Intervention Name(s)
    Provigil
    Intervention Description
    During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy--Relapse Prevention
    Other Intervention Name(s)
    CBT-RP
    Intervention Description
    Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
    Primary Outcome Measure Information:
    Title
    Cocaine use outcome at week 12 (measured with urine toxicology and self-reports)
    Time Frame
    At week 12
    Secondary Outcome Measure Information:
    Title
    Cognitive functioning at week 12 (measured with neuropsychological assessment)
    Time Frame
    At week 12
    Title
    Cocaine withdrawal symptoms throughout (measured with clinical assessments and self-reports)
    Time Frame
    At week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meets DSM IV criteria for current cocaine dependence and is seeking treatment. Used cocaine at least eight days in the past month or reports episodic binges of large amounts of cocaine (at least $150 worth) at least twice per month Able to give informed consent and comply with study procedures. Exclusion Criteria: Meets DSM IV criteria for current mood disorder or past or current mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Baseline 21 item Hamilton Depression Scale scores ≥ 15 History of seizures Chronic organic mental disorder. Significant current suicidal risk. Pregnancy, lactation, or failure in sexually active female participants to use adequate contraceptive methods. Unstable physical disorders, which might make participation hazardous such as hypertension, hepatitis, participants with mildly elevated AST and ALT levels (< 3 X upper limit or normal are acceptable), or diabetes. Coronary vascular disease as indicated by history, or suspected by abnormal EKG or history of cardiac symptoms. Current use of prescribed psychotropic medications. Current use of medications that interact with modafinil: Tricyclic anti-depressants; MOA Inhibitors; diazepam; phenytoin and medications containing Ethinyl Estradiol Known hypersensitivity to modafinil Currently meets DSM-IV criteria for narcolepsy Currently meets DSM-IV criteria for ADHD Currently meets DSM-IV criteria for opioid or sedative-hypnotic dependence. Currently meets criteria for DSM-IV alcohol dependence with evidence of clinically significant physiological dependence in need of medically supervised detoxification. Current cannabis dependence is identified as the main problem-i.e. participants with current DSM-IV cannabis dependence are eligible, as long as cocaine is identified by the participant as the primary substance problem for which they are seeking treatment. Gross visual or auditory impairments First language is not English and received NO formal education in English-speaking school
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Efrat Aharonovich, PhD
    Organizational Affiliation
    Columbia University - New York State Psychiatric Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence

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