Activating Community Support for Substance Users

NCT ID: NCT03194295

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2020-03-16

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.

Conditions

Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Community Support Intervention

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).

Group Type: EXPERIMENTAL

Community Support Intervention Group

Intervention Type: BEHAVIORAL

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.

Standard Care

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.

Group Type: ACTIVE_COMPARATOR

Substance Use Disorder Educational Group

Intervention Type: BEHAVIORAL

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.

Interventions

Community Support Intervention Group

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

Substance Use Disorder Educational Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kidorf, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37553840 (View on PubMed)

Other Identifiers

1R34DA042320-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00130614

Identifier Type: -

Identifier Source: org_study_id