A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Adderall; Amphetamine; Cocaine

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-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).