A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
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ClinicalTrials.gov Identifier: NCT00344565 |
Recruitment Status
:
Completed
First Posted
: June 27, 2006
Last Update Posted
: December 3, 2012
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Tracking Information | ||||
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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 |
Cocaine use outcome at week 12 (measured with urine toxicology and self-reports) [ Time Frame: At week 12 ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00344565 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Cocaine Dependence | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
15 | |||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 | |||
Study Sponsor ICMJE | Research Foundation for Mental Hygiene, Inc. | |||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | |||
Investigators ICMJE |
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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 |