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OpenTrials
Completed

NCT Number: NCT01140334

Treatment for Psychological and Drug Abuse Problems

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addiction Treatment Services

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voucher Reinforcement

Behavioral

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

Behavioral

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 outcomes

  1. Psychiatric Treatment Adherence

    Time frame: Weekly for 12 weeks

    Patient adherence to all scheduled psychiatric sessions (i.e. individual, group, psychiatrist) will be measured weekly for 12 weeks.

  2. Level of Psychiatric Distress

    Time frame: Every 4-weeks for 12 weeks

    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 outcomes

  1. Psychiatric Medication Adherence

    Time frame: Every 4-weeks

    Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.

  2. Substance Use

    Time frame: Weekly for 12-weeks

    Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).

  3. Treatment Retention

    Time frame: Weekly for 12-weeks

    The length of time subjects remain in treatment is tracked throughout the study.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Maximizing Effectiveness of Integrated Treatment Approaches

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 9, 2010
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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