Treatment of Opioid Use: Medication Adherence Therapy (MAT-PLUS)
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|ClinicalTrials.gov Identifier: NCT03567356|
Recruitment Status : Suspended (IRB temporarily suspended study due to COVID-19)
First Posted : June 25, 2018
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependence Opioid-Related Disorders||Other: MAT-PLUS "Helping Hands"||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open-label Treatment as Usual vs. Intervention|
|Masking:||None (Open Label)|
|Official Title:||Medication Adherence Therapy - Psychosocial Leverage Using a Treatment Significant Other|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
No Intervention: Treatment as Usual
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.
Experimental: MAT-Plus Intervention
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.
Other: 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.
- Mean number of XRNTX doses within each group [ Time Frame: 4 months ]Mean Number of XRNTX doses received within 4 months of study
- Rate of opioid relapse during the study period [ Time Frame: Data measured every 2 weeks for the duration of 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.
- Percent Linkage to continuing care [ Time Frame: 1 month ]Percent receiving initial outpatient dose
- Mean Number of days of opioid use [ Time Frame: 4 months ]Mean number of opiate using days in each group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567356
|United States, Maryland|
|Mountain Manor Treatment Center|
|Baltimore, Maryland, United States, 21229|
|Principal Investigator:||Marc Fishman, MD||Maryland Treatment Centers/PHF|