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Opioid Use DisorderMiMPNCT05363371

Minds and Mentors Program- R33

A study testing Minds and Mentors and Twelve Step Intervention Group in people with Opioid Use Disorder and Substance Use Disorders, run by University of Alabama, Tuscaloosa at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The proposed research effort will: The purpose of this study is as follows: 1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program… Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
Minds and Mentors and Twelve Step Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
4 sitesUnited States
Study dates
4 Jan 2022to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 19 and older
  • Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
  • Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
  • Are within maintenance phase of MOUD (not actively detoxing)
  • May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
  • Capable of reading and understanding English
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  • Able to provide written informed consent (i.e. no surrogate)
  • Access to a smartphone or a computer with an internet connection
  • Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)

Who cannot join

  • Significant cognitive impairment
  • Women who are pregnant (does not impact eligibility post study initiation)
  • Actively suicidal or homicidal
  • Active psychosis and/ or
  • Unstable medical conditions that contraindicate proposed treatment
  • Subject Exit criteria:
Show all 10Show fewer
  • Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
  • Newly developed active suicidal or homicidal ideation
  • Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
  • Inability to return for therapy sessions for four consecutive weeks.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Birmingham Veteran Affairs Medical Center

    Birmingham, Alabama, 35233

  • Pathway Healthcare, LLC

    Birmingham, Alabama, 35235

  • Tuscaloosa Veteran Affairs Medical Center

    Tuscaloosa, Alabama, 35404

  • University of Alabama

    Tuscaloosa, Alabama, 35487

Other trials in United States

About this study

Official title: A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R33 Phase)

The proposed research effort will:

The purpose of this study is as follows:

  1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120).
  2. Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues.
  3. Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.
Read the detailed description

Although medications for opioid use disorders (MOUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MOUD regimens remains a challenge. Early studies have demonstrated efficacy of mindfulness-based interventions as adjunctive treatment for substance use disorders (SUD) while reducing substance use and cravings. In addition, non-randomized pilot studies suggest that mindfulness-based interventions may be effective in reducing symptoms of depression and anxiety in individuals undergoing MOUD.

The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition to professional substance abuse therapists (the Minds and Mentors program [MiMP]) in improving adherence to MOUD and reducing relapse rates in a sample of individuals with OUD who are also on MOUD versus a twelve-step facilitation (TSF) program. The MiMP is a twelve-week intervention that uses group therapy and meets once a week for about two hours. The primary outcome measure will is adherence to medications for OUD. The secondary outcome measures will include the demographic covariates, depression, anxiety, stress, quality of life, and cravings. Finally, exploratory outcome measures will include cortisol levels and rates of reactivity to drug cues. This study will randomize participants in either intervention or control group in blocks of five. Data collection will occur at baseline, 8 weeks, 12 weeks (end of treatment) and at 12- week and 24- week follow-up.

Being tested
Minds and Mentors, Twelve Step Intervention Group
Keywords
Opioid Use Disorder, Mindfulness based therapy, Cravings, Relapse prevention, Treatment retention, Depression, Stress, Anxiety, Cortisol, Peer Mentors
Medical subject headings
Opioid-Related Disorders, Substance-Related Disorders, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minds and MentorsBehavioural

    Participants will be randomized into Minds and Mentors to attend weekly group therapy sessions for 12 week. The mindfulness-based relapse prevention therapy intervention will be led by a licensed counselor for eights weeks followed up by four additional sessions led by a certified recovery support specialist (peer mentor).

  • Twelve Step Intervention GroupBehavioural

    Participants will be randomized to the Twelve Step Intervention Group to attend weekly group therapy sessions for 12 week. The twelve step intervention group will be led by a licensed counselor.

Study groups in NCT05363371
Study groupRoleWhat they receive
Mindfulness based relapse prevention and peer mentoringExperimentalTreatment will utilize a group format. The twelve-week mindfulness based relapsed prevention group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, followed by group sessions led by peer mentors for an additional four weeks.
Receives: Behavioral: Minds and Mentors
12 Step Treatment ProgramActive comparatorParticipants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.
Receives: Behavioral: Twelve Step Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence Rate

    Adherence rate operationalized as number of weeks a participant continually receives MOUD as prescribed by primary provider for the duration of the intervention and follow-up period

    Measured: 9 months

Secondary outcomes (6)

  1. Relapse

    Relapse as measured through both self-report utilizing the Timeline Follow-Back (TLFB) and Urine Drug Screen (UDS). The TLFB is a structured interview using calendar-based anchors to assess weekly drug use. UDS is a weekly urine dipstick for substance use; the urine cup has a multi-drug 12 panel test on the cup's surface, which detects several substances including opiates, and uses concentrations levels established by SAMSHA. A participant will be coded as positive for use (i.e., having relapsed) if: (a) the participant self-reported use for that week; or (b) the participant denied use, but provided a positive urine drug screen for opioids. Relapse will be ascertained in 30-day periods. At baseline, a Timeline Followback (TLFB)8 for the 30 days before admission will be obtained (with opioid use separated from other drug use) and a urine drug screen collected. For follow-up assessments, the TLFB for the previous 60 days, 3 months, 3 months post and 6 months post will be obtained.

    Measured: 9 months

  2. Cravings

    Cravings as measured by the Opioid Craving Scale (OCS), a modification of the Cocaine Craving Scale will be utilized to assess opioid craving. The OCS consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). The total score is calculated by averaging the three items.

    Measured: 9 months

  3. Depression

    Depression as measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report that measures depressive symptoms

    Measured: 9 months

  4. Stress

    Stress as measured by the Perceived Stress Scale (PSS), a 10-item self-report of perceived stress

    Measured: 9 months

  5. Anxiety

    Anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report of anxiety

    Measured: 9 months

  6. Quality of Life

    Quality of life as measured by the PROMIS Physical Functioning/ Quality of Life, a 6-item self report of physical functioning and quality of life

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start4 Jan 2022
  3. Primary completion8 Jan 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363371
Sponsor's protocol ID
4R33AT010802-02
Acronym
MiMP
Status last verified
May 2026
First submitted
2 May 2022
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Minds and Mentors and Twelve Step Intervention Group in people with Opioid Use Disorder and Substance Use Disorders, run by University of Alabama, Tuscaloosa at 4 sites 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Adherence Rate (time frame: 9 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 NCT05363371.

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 6 May 2026.

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