Treatment for Psychological and Drug Abuse Problems

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Kidorf, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01140334
First received: June 3, 2010
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Substance Use Disorders
Behavioral: Voucher Reinforcement
Behavioral: Standard Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Maximizing Effectiveness of Integrated Treatment Approaches

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Psychiatric Treatment Adherence [ Time Frame: Weekly for 12 weeks ] [ Designated as safety issue: No ]
    Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.

  • Level of Psychiatric Distress [ Time Frame: Every 4-weeks for 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Psychiatric Medication Adherence [ Time Frame: Every 4-weeks ] [ Designated as safety issue: No ]
    Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.

  • Substance Use [ Time Frame: Weekly for 12-weeks ] [ Designated as safety issue: No ]
    Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).

  • Treatment Retention [ Time Frame: Weekly for 12-weeks ] [ Designated as safety issue: No ]
    The length of time subjects remain in treatment is tracked throughout the study.


Enrollment: 158
Study Start Date: December 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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. In addition, they will be able to earn a voucher incentive for each week of psychiatric compliance.
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.
Active Comparator: Standard On-Site Integrated Care (SOIC).
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
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140334

Locations
United States, Maryland
Addiction Treatment Services
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Michael Kidorf, Ph.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Michael Kidorf, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01140334     History of Changes
Other Study ID Numbers: 1RC1DA028154-01
Study First Received: June 3, 2010
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Psychiatric adherence
Voucher incentives
Methadone treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014