NCT01142986

Brief Summary

This research is being done to evaluate the effectiveness of three different treatment strategies for helping subjects begin and adjust to methadone maintenance treatment at Addiction Treatment Services (ATS). Subjects will be randomly assigned to one of three treatment conditions: 1) Voucher-Based Stepped Care (VBSC) induction, 2) Low-threshold Stepped Care (LTSC) induction, or 3) Routine Stepped Care (RSC) induction. It is hypothesized that subjects in both the VBSC and LTSC condition will remain in treatment longer than subjects in the RSC condition. In addition, it is hypothesized that VBSC and LTSC subjects will have less drug-positive urine samples and will report less infectious disease risk behaviors than RSC subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 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

First Submitted

Initial submission to the registry

June 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

5.3 years

First QC Date

June 10, 2010

Last Update Submit

July 27, 2018

Conditions

Substance Abuse Disorder

Keywords

MethadoneSyringe exchangeTreatment retentionVoucher incentives

Outcome Measures

Primary Outcomes (3)

  • Treatment retention and time to dropout

    The length of time subjects remain in treatment is tracked throughout the study. Retention will be assessed as: 1) percent of subjects remaining in treatment at 3 and 6-months, and 2) time to dropout.

    Weekly for 26 weeks

  • Substance use

    Subjects are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse. Percent positive for opiates, cocaine, benzodiazepines, and cannabis will be evaluated weekly. Self-report use will be assessed for subjects in and out of treatment.

    Weekly for 26 weeks

  • Infectious disease risk behaviors

    Risk behavior will be assessed via the the Risk Assessment Battery (RAB) and Addiction Severity Index at baseline and monthly intervals throughout the study for subjects in and out of treatment.

    Monthly for 6 months

Secondary Outcomes (6)

  • Other problem severity

    Monthly for 6 months

  • Counseling engagement

    Weekly for 26 weeks

  • Methadone dose

    Weekly for 26 weeks

  • Treatment readiness

    Monthly for 6 months

  • Treatment satisfaction

    Monthly for 6 months

  • +1 more secondary outcomes

Study Arms (3)

Low Threshold Stepped Care (LTSC)

EXPERIMENTAL

Subjects in this condition will receive low intensity care during the first 3-months (13 weeks) of study participation, and usual counseling care during the final 3-months (13 weeks) of participation.

Behavioral: Low intensity care

Voucher-Based Stepped Care (VBSC)

EXPERIMENTAL

Subjects in this condition will receive usual counseling care during the entire 6 months of study participation. They will receive voucher reinforcement, and will have the opportunity to earn voucher incentives during the first 3-months of care (13 weeks).

Behavioral: Voucher reinforcement

Routine Stepped-Care (RSC)

NO INTERVENTION

Subjects in this condition will receive usual counseling care during the entire 6-month study (26 weeks).

Interventions

Low intensity careBEHAVIORAL

During the first 3-months (13 weeks), subjects will be scheduled to attend one individual counseling session per month. Subjects will not be required to attend any group counseling sessions during this time. After the first 3-months of care, subjects will start usual counseling care, at which time they will be required to attend one individual counseling session per week, and may be required to attend additional individual and group counseling sessions each week for missed sessions or continued use of drugs or alcohol.

Low Threshold Stepped Care (LTSC)
Voucher reinforcementBEHAVIORAL

Subjects will receive usual counseling care during the 26 weeks of study participation.They will be required to attend one individual counseling session per week, and will be required to attend additional individual and group sessions each week for missed session or continued use of drugs or alcohol.In addition, subjects in this condition will have the opportunity to earn voucher incentives each week during the first 13 weeks of care.These incentives can be earned by taking daily methadone doses and attending all scheduled counseling sessions (individual and group).The first voucher is worth $12.00, and each voucher after that is worth an additional $13.50. Bonuses of $30.00 will be awarded for each 3 consecutive weeks of compliance.The total amount possible to earn in the study is $1329.00. Each week that the subject is not compliant,they will not earn a voucher and the value of the next voucher will be reset to $12.00.The vouchers can be used for goods and services in the community.

Voucher-Based Stepped Care (VBSC)

Eligibility Criteria

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

You may qualify if:

  • Participation in the Baltimore Needle Exchange Program (BNEP)
  • Expressed interest in treatment with methadone.

You may not qualify if:

  • Pregnancy
  • Currently in a treatment program using methadone or other agonist medications
  • Failure to meet DSM-IV criteria for opioid physical dependence and CSAT guidelines for long-term use of opioid agonist medications
  • Presence of an acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; tuberculosis; unstable diabetes, hypertension, and other problems)
  • Presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others (symptoms commonly associated with schizophrenia, bipolar disorder, and other major mental illnesses).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction Treatment Services

Baltimore, Maryland, 21224, United States

Location

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
SPONSOR

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 14, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

US(1)