Substance Use DisordersPhase 2NCT03194295
Activating Community Support for Substance Users
A Phase 2 study testing Community Support Intervention Group and Substance Use Disorder Educational Group in people with Substance Use Disorders, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Community Support Intervention Group and Substance Use Disorder Educational Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 16 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Activating Personal Network Support in Treatment Seeking Substance Users
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.
Read the 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
- Being tested
- Community Support Intervention Group, Substance Use Disorder Educational Group
- Keywords
- Drug-free community support, Methadone maintenance, Social networks
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Support Intervention GroupBehavioural
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.
Substance Use Disorder Educational GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Substance Use Disorder Educational Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Monthly for 3 months
Secondary outcomes (1)
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.
Measured: Monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start10 Jan 2018
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Meets criteria of a phase II non-pharmacological treatment intervention.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michael Kidorf, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194295
- Sponsor's protocol ID
- IRB00130614
- Other IDs
- 1R34DA042320-01A1
- Status last verified
- Sep 2020
- First submitted
- 24 Feb 2017
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37553840
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Personal Network Support in Treatment Seeking Substance Users
- ClinicalTrials.gov ID
- NCT03194295
- Acronym / sponsor ID
- IRB00130614
- Conditions
- Substance Use Disorders
- Keywords
- Drug-free community support, Methadone maintenance, Social networks
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Meets criteria of a phase II non-pharmacological treatment intervention.
| Arm | Type | Receives |
|---|---|---|
| Community Support Intervention | Experimental | Behavioral: Community Support Intervention GroupParticipants 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). |
| Standard Care | Active comparator | Behavioral: Substance Use Disorder Educational GroupParticipants 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Support Intervention GroupThis 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. | Behavioural | Community Support Intervention |
| Substance Use Disorder Educational GroupThis 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. | Behavioural | Standard Care |
Primary outcome
Perceived social support for designated CSP as assessed by the Quality of Relationships Inventory (QRI) "support scale"
Time frame: Monthly for 3 months
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
Time frame: Monthly for 3 months
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.
1 secondary outcome
Substance use and problem severity as assessed by urinalysis testing and Addiction Treatment Index (ASI) composite scores
Time frame: Monthly for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Derived from this study: PubMed 37553840Kidorf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kidorf, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Community Support Intervention Group and Substance Use Disorder Educational Group in people with Substance Use Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived social support for designated CSP as assessed by the Quality of Relationships Inventory (QRI) "support scale" (time frame: Monthly for 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.