Opioid DependenceMAT-PLUSNCT03567356
Treatment of Opioid Use: Medication Adherence Therapy
A study testing MAT-PLUS "Helping Hands" in people with Opioid Dependence and Opioid-Related Disorders, run by Potomac Health Foundations at 1 site in United States.
Trial summary
To test the feasibility and acceptability of a novel approach for improving the delivery and effectiveness of XRNTX treatment for opioid use disorder (OUD) - the MAT-PLUS intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Opioid-Related Disorders
- What is being tested?
- MAT-PLUS "Helping Hands"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18+ with OUD who present for an index episode of residential/inpatient opioid detoxification and seek treatment with XRNTX at community treatment provider Mountain Manor Treatment Center (MMTC)
Who cannot join
- LFTs > 5x ULN
- Psychiatric or medical instability (eg suicidality, psychosis. Sickle Cell disease with frequent crises, etc) that would preclude participation in the trial
- Living situation (location greater than 60 miles from the center, homelessness) that that would preclude participation in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
About this study
Official title: Medication Adherence Therapy - Psychosocial Leverage Using a Treatment Significant Other
To test the feasibility and acceptability of a novel approach for improving the delivery and effectiveness of XRNTX treatment for opioid use disorder (OUD) - the MAT-PLUS intervention. The components of the MAT-PLUS intervention are: XRNTX, initiated during an episode of inpatient/residential treatment and dosed monthly, provides opioid receptor blockade, relapse prevention and overdose prevention; Significant other engagement empowers family members or other designated concerned others, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; Assertive outreach incorporates frequent multi-channel outreach, in a model that specifically targets engagement and motivation for medication adherence; Counselor care coordination and case management focused on medication management and adherence. This objective #1 will be accomplished by conducting a small-scale, 2-arm, open label, RCT pilot study of 4 months of treatment with the MAT-PLUS intervention (significant other engagement and training, medication care coordination by counselors, assertive outreach) + TAU (monthly doses of XRNTX + routine counseling), vs TAU for n=40 (20 per arm) patients with OUD. Adult patients ages 18+ who receive an initial dose of XRNTX during an index episode of inpatient/residential/detox treatment for opioid addiction at a public-sector community treatment program treatment, with intention to continue in outpatient treatment. The experimental arm will receive the MAT-PLUS intervention for 4 months of ongoing outpatient treatment with XRNTX. The control arm will receive 4 months of standard TAU (XRNTX + clinic-based counseling) without MAT-PLUS. At the beginning of the trial an additional small (N = 4 or 5) group of test patients will receive the MAT-PLUS intervention to test and refine the study procedures.
Read the detailed description
Residential detox is an ideal opportunity for initiation of relapse prevention medication, particularly XRNTX, which requires some delay after recent opioid use. But concerns from the field emphasize barriers to induction (as highlighted by the recent results of the CTN51 XBOT study), poor adherence and retention. Clarification is needed on optimal delivery, including a psychosocial treatment platform that is focused more specifically on medication adherence through engagement and empowerment of significant others, and through training and supervision of counselors. Adherence in non-research conditions has been a barrier. To address these gaps, it is proposed this robust intervention, incorporating XRNTX into a multi-component model of care emphasizing adherence enhancement. Assertive outreach is a well-described intervention that is effective in chronic illness, eg in the Assertive Community Treatment (ACT) model for serious and persistent mental illness, and the Integrated Dual Disorder Treatment (IDDT) model for co-occurring disorders. Significant other involvement is a well-established method of improving adherence (e.g. in Network Therapy and Community Reinforcement Approach and Family Training). Significant other involvement is also built into the standard Medication Management model (used in XBOT,COMBINE and others) but it has not been actually used in most implementations. Finally, the use of counselors to drive medication adherence takes advantage of the typically greater contact and alliance that counselors have with patients compared to medical staff.
Several adherence enhancement components are combined synergistically: XRNTX, initiated during residential treatment and dosed monthly; significant other engagement empowers caregivers, providing guidance for encouragement, monitoring and supervision of medication adherence; Assertive outreach incorporates frequent multi-channel contact, case management; Counselor role clarification, training and supervision provides a clear focus on medication adherence.
Primary outcome for this objective is # of doses of XRNTX received within the planned 4 months duration of outpatient treatment. The primary analysis will be a comparison of the mean # of doses in the intervention compared to the control group. Additional analyses will include comparisons of % of subjects receiving all 4 doses, % of subjects receiving at least 1 dose as outpatients as a demonstration of linkage from inpatient to outpatient treatment.
Secondary outcomes for this feasibility objective include process outcomes for feasibility and acceptability, including: # and type of outreach attempts (phone call, email, text, facebook message, etc) and successful contacts with patients and significant others, utilization of TAU counseling, rates of return to treatment after dropout. Lastly, assessments of satisfaction and significant other involvement will be obtained through focus groups conducted separately with patients and significant others to assess qualitative acceptability factors, both barriers and facilitators to success.
- Conditions
- Opioid Dependence, Opioid-Related Disorders
- Being tested
- MAT-PLUS "Helping Hands"
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAT-PLUS "Helping Hands"Other
- Significant other engagement through the "Helping Hands" approach empowers designated concerned helpers, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; 2) Care coordination and case management by counselors to enhance adherence to XRNTX ; 3) Assertive outreach incorporates frequent multi-channel outreach with the goal of achieving XRNTX dosing.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | TAU will contain patients who will be receiving treatment for opioid use disorder through their usual venues without the family engagement, assertive outreach, and home delivery of XRNTX doses. |
| MAT-Plus Intervention | Experimental | The intervention group will receive the multi-component MAT-PLUS treatment: 1) Significant other engagement through the "Helping Hands" approach empowers designated concerned helpers, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; 2) Care coordination and case management by counselors to enhance adherence to XRNTX ; 3) Assertive outreach incorporates frequent multi-channel outreach with the goal of achieving XRNTX dosing. Receives: Other: MAT-PLUS "Helping Hands" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of XRNTX doses within each group
Mean Number of XRNTX doses received within 4 months of study
Measured: 4 months
Secondary outcomes (3)
Rate of opioid relapse during the study period
Relapse = 10 days of use within a 28 day period. Days of opioid use will be assessed through urine toxicology and self report methods.
Measured: Data measured every 2 weeks for the duration of the study period
Percent Linkage to continuing care
Percent receiving initial outpatient dose
Measured: 1 month
Mean Number of days of opioid use
Mean number of opiate using days in each group
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 May 2019
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label Treatment as Usual vs. Intervention
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potomac Health Foundations
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fishman, MD, Principal investigator, Maryland Treatment Centers/PHF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567356
- Sponsor's protocol ID
- MTC002
- Acronym
- MAT-PLUS
- Status last verified
- Apr 2025
- First submitted
- 31 May 2018
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wenzel K, Thomas J, Carrano J, Stidham J, Fishman M. A pilot randomized controlled trial of medication adherence therapy: Psychosocial leverage using a significant other (MAT-PLUS) for individuals on extended-release naltrexone. J Subst Use Addict Treat. 2024 Aug;163:209366. doi: 10.1016/j.josat.2024.209366. Epub 2024 Apr 16.
PubMed 38636807Guo K, Wenzel K, Thomas J, Fishman M. Impact of Assertive Outreach, Individual Involvement, and Significant Other Involvement on XR-NTX Adherence. Subst Use Addctn J. 2026 Jun 30:29767342261460423. doi: 10.1177/29767342261460423. Online ahead of print.
PubMed 42377009
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence Therapy - Psychosocial Leverage Using a Treatment Significant Other
- ClinicalTrials.gov ID
- NCT03567356
- Acronym / sponsor ID
- MAT-PLUS / MTC002
- Conditions
- Opioid Dependence, Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 25 Jun 2018 (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.
To test the feasibility and acceptability of a novel approach for improving the delivery and effectiveness of XRNTX treatment for opioid use disorder (OUD) - the MAT-PLUS intervention. The components of the MAT-PLUS intervention are: XRNTX, initiated during an episode of inpatient/residential treatment and dosed monthly, provides opioid receptor blockade, relapse prevention and overdose prevention; Significant other engagement empowers family members or other designated concerned others, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; Assertive outreach incorporates frequent multi-channel outreach, in a model that specifically targets engagement and motivation for medication adherence; Counselor care coordination and case management focused on medication management and adherence. This objective #1 will be accomplished by conducting a small-scale, 2-arm, open label, RCT pilot study of 4 months of treatment with the MAT-PLUS intervention (significant other engagement and training, medication care coordination by counselors, assertive outreach) + TAU (monthly doses of XRNTX + routine counseling), vs TAU for n=40 (20 per arm) patients with OUD. Adult patients ages 18+ who receive an initial dose of XRNTX during an index episode of inpatient/residential/detox treatment for opioid addiction at a public-sector community treatment program treatment, with intention to continue in outpatient treatment. The experimental arm will receive the MAT-PLUS intervention for 4 months of ongoing outpatient treatment with XRNTX. The control arm will receive 4 months of standard TAU (XRNTX + clinic-based counseling) without MAT-PLUS. At the beginning of the trial an additional small (N = 4 or 5) group of test patients will receive the MAT-PLUS intervention to test and refine the study procedures.
Detailed description
Residential detox is an ideal opportunity for initiation of relapse prevention medication, particularly XRNTX, which requires some delay after recent opioid use. But concerns from the field emphasize barriers to induction (as highlighted by the recent results of the CTN51 XBOT study), poor adherence and retention. Clarification is needed on optimal delivery, including a psychosocial treatment platform that is focused more specifically on medication adherence through engagement and empowerment of significant others, and through training and supervision of counselors. Adherence in non-research conditions has been a barrier. To address these gaps, it is proposed this robust intervention, incorporating XRNTX into a multi-component model of care emphasizing adherence enhancement. Assertive outreach is a well-described intervention that is effective in chronic illness, eg in the Assertive Community Treatment (ACT) model for serious and persistent mental illness, and the Integrated Dual Disorder Treatment (IDDT) model for co-occurring disorders. Significant other involvement is a well-established method of improving adherence (e.g. in Network Therapy and Community Reinforcement Approach and Family Training). Significant other involvement is also built into the standard Medication Management model (used in XBOT,COMBINE and others) but it has not been actually used in most implementations. Finally, the use of counselors to drive medication adherence takes advantage of the typically greater contact and alliance that counselors have with patients compared to medical staff.
Several adherence enhancement components are combined synergistically: XRNTX, initiated during residential treatment and dosed monthly; significant other engagement empowers caregivers, providing guidance for encouragement, monitoring and supervision of medication adherence; Assertive outreach incorporates frequent multi-channel contact, case management; Counselor role clarification, training and supervision provides a clear focus on medication adherence.
Primary outcome for this objective is # of doses of XRNTX received within the planned 4 months duration of outpatient treatment. The primary analysis will be a comparison of the mean # of doses in the intervention compared to the control group. Additional analyses will include comparisons of % of subjects receiving all 4 doses, % of subjects receiving at least 1 dose as outpatients as a demonstration of linkage from inpatient to outpatient treatment.
Secondary outcomes for this feasibility objective include process outcomes for feasibility and acceptability, including: # and type of outreach attempts (phone call, email, text, facebook message, etc) and successful contacts with patients and significant others, utilization of TAU counseling, rates of return to treatment after dropout. Lastly, assessments of satisfaction and significant other involvement will be obtained through focus groups conducted separately with patients and significant others to assess qualitative acceptability factors, both barriers and facilitators to success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label Treatment as Usual vs. Intervention
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –TAU will contain patients who will be receiving treatment for opioid use disorder through their usual venues without the family engagement, assertive outreach, and home delivery of XRNTX doses. |
| MAT-Plus Intervention | Experimental | Other: MAT-PLUS "Helping Hands"The intervention group will receive the multi-component MAT-PLUS treatment: 1) Significant other engagement through the "Helping Hands" approach empowers designated concerned helpers, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; 2) Care coordination and case management by counselors to enhance adherence to XRNTX ; 3) Assertive outreach incorporates frequent multi-channel outreach with the goal of achieving XRNTX dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults age 18+ with OUD who present for an index episode of residential/inpatient opioid detoxification and seek treatment with XRNTX at community treatment provider Mountain Manor Treatment Center (MMTC)
Key exclusion criteria (3 listed)
- LFTs > 5x ULN
- Psychiatric or medical instability (eg suicidality, psychosis. Sickle Cell disease with frequent crises, etc) that would preclude participation in the trial
- Living situation (location greater than 60 miles from the center, homelessness) that that would preclude participation in the trial
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 |
|---|---|---|
| MAT-PLUS "Helping Hands"1) Significant other engagement through the "Helping Hands" approach empowers designated concerned helpers, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; 2) Care coordination and case management by counselors to enhance adherence to XRNTX ; 3) Assertive outreach incorporates frequent multi-channel outreach with the goal of achieving XRNTX dosing. | Other | MAT-Plus Intervention |
Primary outcome
Mean number of XRNTX doses within each group
Time frame: 4 months
Mean Number of XRNTX doses received within 4 months of study
3 secondary outcomes
Rate of opioid relapse during the study period
Time frame: Data measured every 2 weeks for the duration of the study period
Percent Linkage to continuing care
Time frame: 1 month
Mean Number of days of opioid use
Time frame: 4 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 9 Apr 2025.
- Results publication: PubMed 38636807Wenzel K, Thomas J, Carrano J, Stidham J, Fishman M. A pilot randomized controlled trial of medication adherence therapy: Psychosocial leverage using a significant other (MAT-PLUS) for individuals on extended-release naltrexone. J Subst Use Addict Treat. 2024 Aug;163:209366. doi: 10.1016/j.josat.2024.209366. Epub 2024 Apr 16.
- Derived from this study: PubMed 42377009Guo K, Wenzel K, Thomas J, Fishman M. Impact of Assertive Outreach, Individual Involvement, and Significant Other Involvement on XR-NTX Adherence. Subst Use Addctn J. 2026 Jun 30:29767342261460423. doi: 10.1177/29767342261460423. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Marc Fishman, MD principal investigator
Maryland Treatment Centers/PHF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAT-PLUS "Helping Hands" in people with Opioid Dependence and Opioid-Related Disorders, run by Potomac Health Foundations 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 1 inclusion and 3 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 9 Apr 2025. 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.
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?
Mean number of XRNTX doses within each group (time frame: 4 months). 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 NCT03567356, which also lists 2 linked publications.
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 9 Apr 2025.