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Cocaine Dependence | A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Cocaine Dependence research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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-V 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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cocaine Dependence

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Computer-assisted behavior therapyTES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.

Drug:Mixed amphetamine salts80 mg/day of Adderall-XR

Drug:Computer-assisted CBT plus placeboWill receive computer -assisted CBT and placebo (instead of active Adderall-XR)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Computer-assisted Therapy aloneComputer-assisted behavior therapy based on the Community Reinforcement Approach (CRA) to treating cocaine dependence. CRA is skills based treatment program that incorporates coping skills development and contingency management. Participants will attend the clinic 3x per week and receive counseling 2x per week when receiving Behavioral: Computer assisted therapy alone.

Computer-assisted CBT + Adderall-XRPatients who are randomized to the computer-assisted behavior therapy plus mixed amphetamine salts (extended release) arm will have their dose titrated to 80 mg or the maximum tolerated extended release mixed amphetamine salts daily. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial.

Computer-assisted CBT plus placeboPatients who are randomized to the Computer-assisted CBT plus placebo arm will have their medication dose titrated in a fix-flexible dose schedule matching the active medication arm. Participants will be asked to take the medication once per day in the morning or early afternoon and will be maintained on this schedule through week 14 of the trial.

Study Status

Recruiting

Start Date: January 2014

Completed Date: October 2018

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Three weeks of cocaine abstinence

Secondary Outcome: Proportion of cocaine positive urines

Study sponsors, principal investigator, and references

Principal Investigator: Frances R Levin, M.D.

Lead Sponsor: New York State Psychiatric Institute

Collaborator: National Institute on Drug Abuse (NIDA)

More information:https://clinicaltrials.gov/show/NCT01986075

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.

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