NCT03194295

Brief Summary

Efforts to improve methadone maintenance outcomes are often thwarted by strong social networks that reinforce substance use and other risk behaviors. The proposed study the feasibility and preliminary efficacy of a practical community support intervention that employs an alteration model of social network change. The intervention works with patients and at least one drug-free family or friend to support participation in community activities designed to mobilize recovery support and expand personal drug-free social networks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

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

February 24, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

February 24, 2017

Last Update Submit

September 17, 2020

Conditions

Substance Use Disorders

Keywords

Drug-free community supportMethadone maintenanceSocial networks

Outcome Measures

Primary Outcomes (2)

  • Perceived social support for designated CSP as assessed by the Quality of Relationships Inventory (QRI) "support scale"

    The investigators anticipate that Community Support (vs. Standard Care) participants will enjoy greater levels of perceived social support (QRI "support" scale, a continuous measure) at the 3-month evaluation. Mixed model analyses will be used to evaluate condition differences over time (Baseline, Months 1-3). The two remaining QRI subscales ("conflict"; "depth") will also be examined using a similar analytic approach.

    Monthly for 3 months

  • Behavioral and attitudinal support for abstinence as assessed by the IPA

    The investigators anticipate Community Support (vs. Standard Care) participants will enjoy more Behavioral and Attitudinal support for Abstinence (IPA scales; continuous measures) over the 3-month evaluation. Mixed model analyses will be used to evaluate condition differences over time (Baseline, Month 3). The remaining IPA subscales (Social Support for Drug Use; Behavioral Support for Drug Use; Attitudinal Support for DrugUse) will be examined in secondary analyses using a similar approach.

    Monthly for 3 months

Secondary Outcomes (1)

  • Substance use and problem severity as assessed by urinalysis testing and Addiction Treatment Index (ASI) composite scores

    Monthly for 3 months

Study Arms (2)

Community Support Intervention

EXPERIMENTAL

Participants randomized to this condition will be scheduled to attend a 12-week (1x/wk for one hour) manual-guided Community Support Intervention Group, which requires methadone maintenance treatment (MMT) participants to attend the group with a drug-free family member or friend (community support person; CSP).

Behavioral: Community Support Intervention Group

Standard Care

ACTIVE COMPARATOR

Participants randomized to this condition will be scheduled to attend a 12-week (1x/wk for one hour) manual-guided Substance Use Disorder Educational Group as an attention-control for the intervention described in the experimental condition.

Behavioral: Substance Use Disorder Educational Group

Interventions

Community Support Intervention GroupBEHAVIORAL

This 12-week community support intervention is designed to activate and harness the powerful influences of drug-free family and friends to enhance recovery support and participation in community activities. Addiction Treatment Services (ATS) participants and their CSPs will be directed to participate in recovery-oriented community activities together 2 times per week and work together toward developing regular drug-free social support for the ATS participant. The group provides an opportunity for both the participant and CSP to discuss their experiences participating in the scheduled activities. For those electing not to engage in community activities, problem-solving strategies will be used to remove obstacles to participation, with other group members providing support and encouragement.

Community Support Intervention
Substance Use Disorder Educational GroupBEHAVIORAL

This 12-week educational group is designed as an attention-control group. Group topics include: 1) definition of substance dependence, 2) the disease model, 3) medical aspects, 4) mood, 5) personality, 6) self-esteem, 7) relapse prevention, 8) HIV/AIDS, 9) anger, 10) negative thinking, 11) nutrition, and 12) assertiveness. Participants will be assigned 2 homework assignments each week based on the topic.

Standard Care

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ATS treatment participation of more than 4-weeks
  • Submission of at least one drug-positive urine sample
  • Expressed willingness to include a drug-free support person in treatment

You may not qualify if:

  • Pregnancy
  • Acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; unstable diabetes)
  • Presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
  • Unable to read.
  • Submission of a drug-positive urine sample
  • Pregnancy
  • Acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; unstable diabetes)
  • Presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
  • Unable to read.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Kidorf M, Peirce J, Brooner RK, Yan H, Latkin C. Feasibility and preliminary efficacy of a community support intervention for people with opioid use disorder. Am J Addict. 2023 Nov;32(6):554-562. doi: 10.1111/ajad.13457. Epub 2023 Aug 8.

    PMID: 37553840DERIVED

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
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Meets criteria of a phase II non-pharmacological treatment intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

June 21, 2017

Study Start

January 10, 2018

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)