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 145 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

• Meets DSM-V criteria for cocaine use disorder.
• Used cocaine at least four days in the past month.
• Age 18-60.
• Able to give informed consent and comply with study procedures

Exclusion criteria

• Meets DSM-V criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
• 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.
• History of seizures, unexplained loss of consciousness, or traumatic brain injury.
• History of allergic reaction to candidate medication (amphetamine).
• Significant current suicidal risk.
• Pregnancy, lactation, or failure in sexually active female patients to use adequate contraceptive methods.
• Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension, acute hepatitis, uncontrolled diabetes.
• Elevated transaminase levels (> 3x the normal limit).
• Coronary vascular disease
• History of failure to respond to a previous adequate trial of the candidate medication.
• Current physiological dependence on any other substance other than nicotine or cannabis that would require a medically supervised detoxification.
• Currently being prescribed psychotropic medication by another physician.
• Are legally mandated (e.g. to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
• Body Mass Index (BMI) < 18kg/m2. (amphetamine may produce weigh loss thus a minimum BMI cut-off is being used for study inclusion).