A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

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.

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).