Treatment for Psychological and Drug Abuse Problems

Not Applicable

Completed

• Conditions: Substance Use Disorders
• Interventions: Behavioral: Voucher Reinforcement; Behavioral: Standard Control

• Registration Number: NCT01140334
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care. Patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular appointments with a psychiatrist. Patients will be randomly assigned to standard psychiatric care or standard psychiatric care plus voucher incentives. These incentives can be earned by successfully attending all scheduled psychiatric appointments each week. The investigators expect that patients in the voucher condition will attend more psychiatric sessions, which will lead to greater reductions in psychiatric distress.

Detailed Description

Male and female opioid-dependent patients at Addiction Treatment Services with any current psychiatric disorder (N = 100) will be randomly assigned to one of two psychiatric service conditions: 1) reinforced on-site integrated care (ROIC), with voucher incentives contingent on attending weekly psychiatric sessions; or 2) standard on-site integrated care (SOIC). Participants in both conditions will receive access to the same schedule and range of psychiatric and substance abuse treatment services. Participants will be assessed for 3-months post-randomization to determine rates of service utilization and adherence to psychiatric care, changes in scope and severity of psychiatric and psychosocial problems, and rates of drug use and treatment retention. Positive findings would have considerable heuristic and health care policy and practice implications. The entire study, including dissemination of the major findings at a national meeting and submission of the first manuscript, is designed to be completed within 2-years.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• At least 18 years of age
• Voluntarily seeking psychiatric treatment
• Meets DSM-IV criteria for opiate dependence
• Meets FDA/CSAT guidelines for methadone maintenance
• Meets DSM-IV criteria for at least one current psychiatric disorder

Exclusion Criteria

• Pregnancy
• Onset or acute exacerbation of a medical illness requiring immediate and intense care
• An organic mental disorder (e.g., delirium, dementia)
• Current participation in psychiatric care
• Mandatory psychiatric treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reinforced On-Site Integrated Care (ROIC)	Voucher Reinforcement	Patients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. In addition, they will be able to earn a voucher incentive for each week of psychiatric compliance.
Standard On-Site Integrated Care (SOIC).	Standard Control	Patients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week.

Primary Outcome Measures

Name	Time	Method
Psychiatric Treatment Adherence	Weekly for 12 weeks	Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.
Level of Psychiatric Distress	Every 4-weeks for 12 weeks	Patients will complete the Addiction Severity Index (ASI) and the SCL-90 every 4-weeks, for 12-weeks, to measure their current levels of psychiatric distress.

Secondary Outcome Measures

Name	Time	Method
Treatment Retention	Weekly for 12-weeks	The length of time subjects remain in treatment is tracked throughout the study.
Psychiatric Medication Adherence	Every 4-weeks	Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.
Substance Use	Weekly for 12-weeks	Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).

Trial Locations

Locations (1)

Addiction Treatment Services; 🇺🇸 Baltimore, Maryland, United States