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Activating Community Support for Substance Users

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Community Support Intervention Group
Substance Use Disorder Educational Group
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Drug-free community support, Methadone maintenance, Social networks

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (for the ATS participant):

  • 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

Exclusion Criteria (for the ATS participant):

  • 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.

Exclusion Criteria (for the CSPs)

  • 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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Community Support Intervention

Standard Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Substance use and problem severity as assessed by urinalysis testing and Addiction Treatment Index (ASI) composite scores
The investigators anticipate Community Support (vs. Standard Care) participants will have lower rates of "any" drug-positive urine samples (i.e., opioid, cocaine, sedatives, and/or cannabis) over the 3-month evaluation. Drug-positive urine samples will be treated as a dichotomous variable. Generalized estimating equation (GEE) analysis will be used to evaluate condition differences over time (Baseline, Months 1-3). Specific classes of drugs (opioid, cocaine, sedative, cannabis positive urinalysis tests) will be examined using a similar analytic approach. Secondary analyses will use mixed model analyses to evaluate condition differences in ASI self-report drug composite scores over time (Baseline, Months 1-3). The remaining ASI composite scores will be examined using a similar approach.

Full Information

First Posted
February 24, 2017
Last Updated
September 17, 2020
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03194295
Brief Title
Activating Community Support for Substance Users
Official Title
Activating Personal Network Support in Treatment Seeking Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Opioid-dependent individuals in methadone maintenance have high rates of illicit drug and alcohol use. The individual and public health concerns of poorly and partially treated substance use include social, medical, psychiatric, and healthcare costs. Efforts to improve outcomes are often thwarted by strong social networks that reinforce substance use and other high-risk drug use and sexual behaviors. Many urban substance users lack the financial resources to simply move away from adverse community influences. While clinical providers are well aware of the power of social network influences, existing research provides relatively little direction about how to help substance users change "people, places, and things." An under-explored strategy to achieve this desired outcome is to mobilize social support found in the personal social networks of people with substance use disorder. A considerable amount of research demonstrates that people with substance use disorder routinely have drug-free family or friends in their social networks, and that these individuals are terribly underutilized for supporting recovery efforts. Social support is reliably associated with good health behaviors and more positive and sustained substance abuse treatment outcomes. The inclusion of drug-free family and friends also provides a pathway to modify social networks by facilitating activity with other drug-free people within and outside of the patient's social network. This type of work supports an alteration model of network change. This protocol uses an alteration model to develop a promising 12-week community support intervention designed to activate and harness the powerful influences of drug-free family and friends to enhance recovery support and participation in community activities. This highly structured and manual-guided therapeutic group works with patients and at least one drug-free family member or friend (community support person -- CSP) to expand the quantity and quality of the patients' drug-free social network, and to reduce and eliminate interactions with active drug users. This outcome is achieved via a series of "homework" assignments that require the patient and CSP to participate together in two drug-free activities per week that include the presence of other drug-free individuals (e.g., Narcotics Anonymous (NA)/Alcoholics Anonymous (AA), religious activities), and to discuss their experiences within the group setting. This intervention will be compared to Standard Care that includes a substance abuse education group with weekly homework. Specific aims evaluate feasibility outcomes and the extent to which the intervention supports an alteration model. Short-term efficacy will be assessed using measures of perceived social support and network support for abstinence. Secondary outcomes will evaluate substance use and psychosocial outcomes. Data will support a larger-scale randomized clinical trial (RCT) better isolating the clinical benefits of activating existing social support and facilitating community involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Drug-free community support, Methadone maintenance, Social networks

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Meets criteria of a phase II non-pharmacological treatment intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Support Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Support Intervention Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Substance Use Disorder Educational Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived social support for designated CSP as assessed by the Quality of Relationships Inventory (QRI) "support scale"
Description
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.
Time Frame
Monthly for 3 months
Title
Behavioral and attitudinal support for abstinence as assessed by the IPA
Description
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.
Time Frame
Monthly for 3 months
Secondary Outcome Measure Information:
Title
Substance use and problem severity as assessed by urinalysis testing and Addiction Treatment Index (ASI) composite scores
Description
The investigators anticipate Community Support (vs. Standard Care) participants will have lower rates of "any" drug-positive urine samples (i.e., opioid, cocaine, sedatives, and/or cannabis) over the 3-month evaluation. Drug-positive urine samples will be treated as a dichotomous variable. Generalized estimating equation (GEE) analysis will be used to evaluate condition differences over time (Baseline, Months 1-3). Specific classes of drugs (opioid, cocaine, sedative, cannabis positive urinalysis tests) will be examined using a similar analytic approach. Secondary analyses will use mixed model analyses to evaluate condition differences in ASI self-report drug composite scores over time (Baseline, Months 1-3). The remaining ASI composite scores will be examined using a similar approach.
Time Frame
Monthly for 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (for the ATS participant): 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 Exclusion Criteria (for the ATS participant): 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. Exclusion Criteria (for the CSPs) 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.
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
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Activating Community Support for Substance Users

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