Clinical trial NCT01140334: Treatment for Psychological and Drug Abuse Problems
Official title: Maximizing Effectiveness of Integrated Treatment Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Psychiatric adherence
Voucher incentives
Methadone treatment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-09
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychiatric Treatment Adherence
timeFrame: Weekly for 12 weeks
measure: Level of Psychiatric Distress
timeFrame: Every 4-weeks for 12 weeks
Secondary outcomes:
measure: Psychiatric Medication Adherence
timeFrame: Every 4-weeks
measure: Substance Use
timeFrame: Weekly for 12-weeks
measure: Treatment Retention
timeFrame: Weekly for 12-weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Addiction Treatment Services
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael Kidorf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.drugalcdep.2013.06.005. Epub 2013 Jul 15.