Treatment for Psychological and Drug Abuse Problems

Substance Use Disorders Clinical Trial

Official title:

Maximizing Effectiveness of Integrated Treatment Approaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140334
• Other study ID #: 1RC1DA028154-01
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: September 19, 2013
• Start date: December 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Voucher Reinforcement
Patients in this condition will be able to earn a voucher for each week that they have attended all scheduled psychiatric sessions. These sessions may include individual therapy appointments, group therapy appointments, or psychiatrist appointments. Each voucher will be worth $25, and can be exchanged for goods and services that will be purchased by a research assistant. The maximum amount of voucher earnings over the study is $300.
• 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. No voucher incentive will be offered in this condition.

Locations

Country	Name	City	State
United States	Addiction Treatment Services	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kidorf M, Brooner RK, Gandotra N, Antoine D, King VL, Peirce J, Ghazarian S. Reinforcing integrated psychiatric service attendance in an opioid-agonist program: a randomized and controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):30-6. doi: 10.1016/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychiatric Treatment Adherence	Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.	Weekly for 12 weeks	No
Primary	Level of Psychiatric Distress	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.	Every 4-weeks for 12 weeks	No
Secondary	Psychiatric Medication Adherence	Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.	Every 4-weeks	No
Secondary	Substance Use	Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).	Weekly for 12-weeks	No
Secondary	Treatment Retention	The length of time subjects remain in treatment is tracked throughout the study.	Weekly for 12-weeks	No