search
Back to results

Treatment for Psychological and Drug Abuse Problems

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voucher Reinforcement
Standard Control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders focused on measuring Psychiatric adherence, Voucher incentives, Methadone treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addiction Treatment Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reinforced On-Site Integrated Care (ROIC)

Standard On-Site Integrated Care (SOIC).

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Psychiatric Treatment Adherence
Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured 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.

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2010
Last Updated
September 19, 2013
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01140334
Brief Title
Treatment for Psychological and Drug Abuse Problems
Official Title
Maximizing Effectiveness of Integrated Treatment Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Psychiatric adherence, Voucher incentives, Methadone treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reinforced On-Site Integrated Care (ROIC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard On-Site Integrated Care (SOIC).
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Voucher Reinforcement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychiatric Treatment Adherence
Description
Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.
Time Frame
Weekly for 12 weeks
Title
Level of Psychiatric Distress
Description
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.
Time Frame
Every 4-weeks for 12 weeks
Secondary Outcome Measure Information:
Title
Psychiatric Medication Adherence
Description
Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.
Time Frame
Every 4-weeks
Title
Substance Use
Description
Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).
Time Frame
Weekly for 12-weeks
Title
Treatment Retention
Description
The length of time subjects remain in treatment is tracked throughout the study.
Time Frame
Weekly for 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kidorf, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Treatment Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23866988
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.
Results Reference
result

Learn more about this trial

Treatment for Psychological and Drug Abuse Problems

We'll reach out to this number within 24 hrs