Clinical trial NCT01986075: A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Official title: A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cocaine Dependence
Keywords: Cocaine Dependence Treatment
Computer-assisted therapy
Pharmacotherapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-11-18
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Following an initial 4 week period where participants received computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM), individuals who failed to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned, in parallel, to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.
Primary purpose: TREATMENT

Brief 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.

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 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.

Eligibility 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).

Primary outcomes:
measure: Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.
timeFrame: weeks 12-14 of trial
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: STARS
state: New York
Study officials:
affiliation: Columbia University/New York State Psychiatric Institute
name: Frances R Levin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Blevins D, Carpenter KM, Martinez D, Mariani JJ, Levin FR. An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders. Contemp Clin Trials. 2020 Nov;98:106187. doi: 10.1016/j.cct.2020.106187. Epub 2020 Oct 18.