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A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence

Intervention: Computer-assisted behavior therapy (Behavioral); Mixed amphetamine salts (Drug); Computer-assisted CBT plus placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Frances R Levin, M.D., Principal Investigator, Affiliation: Columbia University/New York State Psychiatric Institute

Summary

This study will investigate a treatment strategy in which a computer-assisted behavioral intervention will be used to help individuals stop their use of cocaine. A medication will be combined with the behavioral treatment among those individuals who do not respond to the behavioral intervention alone. The primary hypothesis of the study is that among cocaine dependent individuals who fail to respond to an initial trial of behavioral therapy, a greater proportion of individuals will benefit from the combined treatment (behavior therapy plus medication) compared to individuals in the comparison group.

Clinical Details

Official title: A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Three weeks of cocaine abstinence

Secondary outcome: Proportion of cocaine positive urines

Detailed description: Cocaine Dependence is associated with substantial social, physical, and neurobiological problems. Psychosocial treatments can be helpful for many individuals. However, a significant proportion of individuals do not benefit from counseling alone. Our research group has demonstrated that deficient dopamine transmission, predicts poor response to a behavioral treatment and that a regiment that included an agonist replacement strategy with stimulants maybe effective for promoting abstinence in severe cocaine dependent patients. In this 15-week study 155 treatment-seeking cocaine dependent participants will receive a computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM). The counseling approach will include both computer-assisted life skills training via and counseling. Individuals who fail to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Meets DSM-V criteria for cocaine use disorder. 2. Used cocaine at least four days in the past month. 3. Age 18-60. 4. Able to give informed consent and comply with study procedures Exclusion Criteria: 1. Meets DSM-IV criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. 2. Participants with MDD, with symptom severity that exceeds a HAM-D score of 20, and/or any other current Axis I psychiatric disorder as defined by DSM-V supported by the MINI that in the investigator's judgment are unstable, would be disrupted by study medication, or are likely to require specialized pharmacotherapy or psychotherapy during the study period. 3. History of seizures, unexplained loss of consciousness, or traumatic brain injury. 4. History of allergic reaction to candidate medication (amphetamine). 5. Significant current suicidal risk. 6. Pregnancy, lactation, or failure in sexually active female patients to use adequate contraceptive methods. 7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension, acute hepatitis, uncontrolled diabetes. 8. Elevated transaminase levels (> 3x the normal limit). 9. Coronary vascular disease 10. History of failure to respond to a previous adequate trial of the candidate medication. 11. Current physiological dependence on any other substance other than nicotine or cannabis that would require a medically supervised detoxification. 12. Currently being prescribed psychotropic medication by another physician. 13. Are legally mandated (e. g. to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program. 14. Body Mass Index (BMI) < 18kg/m2. (amphetamine may produce weigh loss thus a minimum BMI cut-off is being used for study inclusion).

Locations and Contacts

STARS, New York, New York 10032, United States; Recruiting
Kenneth M Carpenter, Ph.D., Phone: 212-923-3031, Email: carpent@nyspi.columbia.edu
Frances R Levin, M.D., Principal Investigator
Kenneth M Carpenter, Ph.D., Principal Investigator
Additional Information

Click here for more information about the study and clinic

Related publications:

Bickel WK, Marsch LA, Buchhalter AR, Badger GJ. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008 Apr;16(2):132-43. doi: 10.1037/1064-1297.16.2.132.

Starting date: January 2014
Last updated: March 30, 2015

Page last updated: August 20, 2015

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