NCT01140334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

2.7 years

First QC Date

June 3, 2010

Last Update Submit

September 19, 2013

Conditions

Keywords

Psychiatric adherenceVoucher incentivesMethadone treatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • Psychiatric Medication Adherence

    Every 4-weeks

  • Substance Use

    Weekly for 12-weeks

  • Treatment Retention

    Weekly for 12-weeks

Study Arms (2)

Reinforced On-Site Integrated Care (ROIC)

EXPERIMENTAL

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.

Behavioral: Voucher Reinforcement

Standard On-Site Integrated Care (SOIC).

ACTIVE COMPARATOR

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.

Behavioral: Standard Control

Interventions

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.

Reinforced On-Site Integrated Care (ROIC)

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.

Standard On-Site Integrated Care (SOIC).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction Treatment Services

Baltimore, Maryland, 21224, United States

Location

Related 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.drugalcdep.2013.06.005. Epub 2013 Jul 15.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael Kidorf, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 9, 2010

Study Start

December 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations