Clinical trial NCT03194295: Activating Community Support for Substance Users
Official title: Activating Personal Network Support in Treatment Seeking Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Use Disorders
Keywords: Drug-free community support
Methadone maintenance
Social networks
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-06-21
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Meets criteria of a phase II non-pharmacological treatment intervention.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Perceived social support for designated CSP as assessed by the Quality of Relationships Inventory (QRI) "support scale"
timeFrame: Monthly for 3 months
measure: Behavioral and attitudinal support for abstinence as assessed by the IPA
timeFrame: Monthly for 3 months
Secondary outcomes:
measure: Substance use and problem severity as assessed by urinalysis testing and Addiction Treatment Index (ASI) composite scores
timeFrame: Monthly for 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael Kidorf, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: