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

Tracking Information
First Submitted Date ICMJE	June 26, 2006
First Posted Date ICMJE	June 27, 2006
Last Update Posted Date	December 3, 2012
Study Start Date ICMJE	November 2005
Actual Primary Completion Date	December 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 30, 2012)	Cocaine use outcome at week 12 (measured with urine toxicology and self-reports) [ Time Frame: At week 12 ]
Original Primary Outcome Measures ICMJE; (submitted: June 26, 2006)	Treatment retention outcome (number of weeks of treatment attendance); Cocaine use outcome at week 12 (measured with urine toxicology and self-reports)
Change History	Complete list of historical versions of study NCT00344565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 30, 2012)	Cognitive functioning at week 12 (measured with neuropsychological assessment) [ Time Frame: At week 12 ]; Cocaine withdrawal symptoms throughout (measured with clinical assessments and self-reports) [ Time Frame: At week 12 ]
Original Secondary Outcome Measures ICMJE; (submitted: June 26, 2006)	Cognitive functioning at week 12 (measured with neuropsychological assessment); Cocaine withdrawal symptoms throughout (measured with clinical assessments and self-reports)
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
Official Title ICMJE	Combined Treatment of Modafinil and Cognitive Behavioral Therapy for Cocaine Dependence
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Cocaine Dependence
Intervention ICMJE	Drug: Modafinil 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. Other Name: Provigil; Behavioral: Cognitive Behavioral Therapy--Relapse Prevention Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP) Other Name: CBT-RP
Study Arms	Placebo Comparator: Placebo Placebo, was matched to modafinil up to 400 mg/day. Patients also receive motivational interviewing and Cognitive Behavioral Therapy—Relapse Prevention (CBT-RP) Interventions: Drug: Modafinil Behavioral: Cognitive Behavioral Therapy--Relapse Prevention; Active Comparator: Modafinil Modafinil (Active comparator). Patients received motivational interviewing and Cognitive Behavioral Therapy--relapse prevention (CBT-RP) Interventions: Drug: Modafinil Behavioral: Cognitive Behavioral Therapy--Relapse Prevention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 30, 2012)	15
Original Enrollment ICMJE; (submitted: June 26, 2006)	30
Actual Study Completion Date	March 2007
Actual Primary Completion Date	December 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00344565
Other Study ID Numbers ICMJE	# 5148; K23DA016743-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.
Study Sponsor ICMJE	Research Foundation for Mental Hygiene, Inc.
Collaborators ICMJE	National Institute on Drug Abuse (NIDA)
Investigators ICMJE	Principal Investigator: Efrat Aharonovich, PhD Columbia University - New York State Psychiatric Institute
PRS Account	Research Foundation for Mental Hygiene, Inc.
Verification Date	November 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP