A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

A Sequenced Behavioral and Medication Intervention for Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986075
• Other study ID #: #6850
• Secondary ID: R01DA034087-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2014
• Est. completion date: January 2021

Study information

• Verified date: January 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Behavioral:
• Computer-assisted behavior therapy
TES 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 Salts- Extended Release (MAS-ER)
80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT
• Placebo
Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)

Locations

Country	Name	City	State
United States	STARS	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Those Achieving Three Consecutive Weeks of Cocaine Abstinence at the End of the Trial.	The primary outcome measure will be a binary indicator (yes or no) of at least 3 consecutive weeks of urine toxicology confirmed self-reported abstinence during the last three weeks of the trial.	weeks 12-14 of trial

External Links

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