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

NCT00344565 | Completed Phase 2 DMC

• 2 other identifiers: # 5148K23DA016743-03
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

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

  At week 12

Secondary Outcomes (2)

• Cognitive functioning at week 12 (measured with neuropsychological assessment)

  At week 12

• Cocaine withdrawal symptoms throughout (measured with clinical assessments and self-reports)

  At week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Modafinil; Behavioral: Cognitive Behavioral Therapy--Relapse Prevention

Modafinil

ACTIVE COMPARATOR

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

Drug: Modafinil; Behavioral: Cognitive Behavioral Therapy--Relapse Prevention

Interventions

Modafinil DRUG

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.

Also known as: Provigil

Modafinil; Placebo

Cognitive Behavioral Therapy--Relapse Prevention BEHAVIORAL

Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)

Also known as: CBT-RP

Modafinil; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

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

Study Officials

• Efrat Aharonovich, PhD

  Columbia University - New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 26, 2006
• First Posted: June 27, 2006
• Study Start: November 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: December 3, 2012

Record last verified: 2012-11