Substance Use Disorders Clinical Trial
Official title:
Activating Personal Network Support in Treatment Seeking Substance Users
Verified date | September 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | March 16, 2020 |
Est. primary completion date | March 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. |
Monthly for 3 months |
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