Opioid UseNCT03894501
Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment
A study testing Mindfulness Oriented Recovery Enhancement and Methadone program behavioral treatment as usual in people with Opioid Use and Chronic Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This pilot study aims to evaluate the impact of a novel intervention, Mindfulness Oriented Recovery Enhancement (MORE), on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Chronic Pain
- What is being tested?
- Mindfulness Oriented Recovery Enhancement and Methadone program behavioral treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- English-speaking
- Been in methadone treatment for at least 3 months
- Experience a non-malignant pain (with an intensity level of 8 or higher on the Gracely Box Scale) for a duration of 2 months or longer.
Who cannot join
- Exhibit cognitive impairment (score <24 on the Mini Mental Status Exam)
- Exhibit psychosis (positive SCID Psychotic Screen),
- Are at suicidal risk (positive score on ASQ Suicide Risk Screening Tool)
- Unable to attend group sessions due to distance, work, commitments or other logistical problems,
- Are currently pregnant or breastfeeding
- Are planning to be pregnant or breastfeeding the next 16 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot
This pilot study aims to evaluate the impact of a novel intervention, Mindfulness Oriented Recovery Enhancement (MORE), on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). The main goal of this pilot study is to test the feasibility of our study methods before conducting a clinical trial to assess MORE with respect to a range of clinical outcomes. This study will involve a 2-arm individually randomized controlled trial design that compares MORE and treatment as usual (TAU).
Read the detailed description
This pilot study is a 2-arm individually randomized controlled trial design in which outcomes of MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as usual (TAU). In the pilot study (R21; N=30), we will randomize MMT patients with chronic pain to MORE (n=15) or TAU (n=15). This study phase will focus on establishing study feasibility in recruiting, retaining, and following up study participants before progressing to a larger Phase II clinical trial (R33, N=150). Participants with pain who are receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics in New Jersey.
Participants will be recruited through flyers posted in the clinics, being approached by research assistants in the waiting room of their usual methadone clinic, and referral by clinic staff. The number of individuals who contact the study staff through the flyers or referral and who are approached by study staff in the clinics will be tracked. Number of individuals who refuse study participation and who consent to the study will also be tracked. If an individual is interested in study participation, a trained research assistant will lead the individual through the informed consent process in a private space.
Since MORE is a closed group, we will randomize cohorts of 14-16 participants (depending on speed of recruitment) at each site to TAU or MORE with block randomization. Once we 14-16 participants at a particular clinic, we will randomize participants to MORE or TAU, and the MORE group will begin.
Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions led by a clinic or study counselor. Each session will contain 6-8 participants and take place in a private room at the methadone clinic. Attendance at each session and reasons for missing sessions will be recorded Participants randomized to the control condition will continue receiving treatment as usual.
All study participants will partake in a total of three interviews lasting up to 90 minutes and occurring at baseline, 8- and 16- weeks post-baseline in private rooms in the methadone clinics. Each participant will also have a urine or saliva sample collected during each assessment. All attempts to reach participants to schedule follow-up assessments will be tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones, which will be provided to each participant by study staff. EMA participation will require the participant to respond to twice-daily prompts in which they will be asked a series of brief questions regarding their current mood and exposure to opioid triggers. Additionally, subjects will be asked to initiate responses when they experience serious craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.
- Conditions
- Opioid Use, Chronic Pain
- Being tested
- Mindfulness Oriented Recovery Enhancement, Methadone program behavioral treatment as usual
- Keywords
- opioid, chronic pain, methadone, mindfulness
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Oriented Recovery EnhancementBehavioural
Also called MORE
MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
Methadone program behavioral treatment as usualBehavioural
Also called Treatment as Usual, TAU
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Experimental | The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day. Receives: Behavioral: Mindfulness Oriented Recovery Enhancement |
| Methadone program behavioral treatment as usual | Other | In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups. Receives: Behavioral: Methadone program behavioral treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Interest
The number of individuals who express interest in the study.
Measured: Baseline
Study Refusal
The number of individuals who who refuse participation when offered.
Measured: Baseline
Individuals Screened
The number of individuals screened and eligible/ineligible.
Measured: Baseline (study enrollment)
Individuals Consented.
The number of individuals consented.
Measured: Baseline (study enrollment)
Refusal After/During Consent Process.
The number of individuals who refuse participation after/during consent process.
Measured: Enrollment
Mean Sessions Completed
The mean number of sessions completed by study participants in the MORE intervention.
Measured: At 8-weeks (post treatment period completion).
Percentage of Sessions Completed
The mean percentage of sessions completed by study participants randomized to MORE.
Measured: At 8-weeks (post treatment period completion).
Number Who Drop Out
Number of participants who drop out of the study.
Measured: At 16 weeks.
Percentage Who Drop Out
Percentage of participants who drop out of the study.
Measured: At 16 weeks.
Baselines Completed
The number of participants who complete baseline assessments.
Measured: At baseline,
Percentage Baselines Completed
Percentage of people who completed baseline assessments.
Measured: At baseline,
8-weeks Completed
The number of participants who complete 8-week assessments.
Measured: At 8-weeks.
Percentage 8-Weeks Completed
Percentage of participants who completed 8-week assessments.
Measured: At 8-weeks.
16-Weeks Completed
The number of participants who completed 16-week assessments.
Measured: At 16-weeks.
Percentage of 16-Weeks Completed
Percentage of participants who completed 16-week assessments.
Measured: At 16-weeks.
Secondary outcomes (6)
Days of Illicit Drug Use
Research staff asked participants if they used various drugs (i.e., heroin, cocaine, opioids, marijuana, amphetamines, inhalants, hallucinogens, benzodiazepines, zolpidem, methylphenidate, or other drugs) in the past 30 days and the number of days of use for each drug in the past 30 days. "Days of illicit drug use" was determined by counting the number of days each participant used drugs based on past-30 day self-reports at the16-week assessments.
Measured: 16-weeks
Days of Illicit Opioid Use
Research staff asked participants if they used illicit opioids in the past 30 days and the number of days of use for each drug in the past 30 days. "Days of illicit opioid use" was determined by counting the number of days each participant used illicit opioids based on past-30 day self-reports at the 16-week assessment.
Measured: 16-weeks
Opioid Craving
Research staff assessed opioid craving with a version of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) that was adapted to assess craving to opioids at 16-weeks. Scores range from 0 to 36. Higher scores indicate greater craving.
Measured: 16-weeks
Pain Level.
Pain was assess with the pain subscale (i.e., bodily pain severity and interference) of the RAND 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better functioning, health, and well-being and less pain, limitations, and symptom severity or interference as compared to lower scores.
Measured: 16-weeks
Depression Level.
Depression was measured with Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a widely used valid and reliable measure that consists of 20 items with potential scores ranging from 0 to 60. A score above 16 on the CES-D indicates clinically significant symptoms of depression. Higher scores on the CES-D indicates greater depression.
Measured: 16-weeks
Anxiety Level.
Anxiety was measured with the Beck Anxiety Inventory (BAI). The BAI is also a widely used, reliable, and valid scale that consists of 21 items with potential scores ranging from 0 to 63. A score of 16 or higher indicates clinically sig-nificant symptoms of anxiety. A higher score on the BAI indicates greater anxiety.
Measured: 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start31 Jan 2019
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey
- Investigators
- Nina A Cooperman, PsyD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894501
- Sponsor's protocol ID
- 2018001127
- Status last verified
- Nov 2021
- First submitted
- 26 Mar 2019
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 30 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.
Publications
Garland EL, Hanley AW, Kline A, Cooperman NA. Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. Drug Alcohol Depend. 2019 Oct 1;203:61-65. doi: 10.1016/j.drugalcdep.2019.07.007. Epub 2019 Aug 5.
PubMed 31404850
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot
- ClinicalTrials.gov ID
- NCT03894501
- Acronym / sponsor ID
- 2018001127
- Conditions
- Opioid Use, Chronic Pain
- Keywords
- opioid, chronic pain, methadone, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to evaluate the impact of a novel intervention, Mindfulness Oriented Recovery Enhancement (MORE), on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). The main goal of this pilot study is to test the feasibility of our study methods before conducting a clinical trial to assess MORE with respect to a range of clinical outcomes. This study will involve a 2-arm individually randomized controlled trial design that compares MORE and treatment as usual (TAU).
Detailed description
This pilot study is a 2-arm individually randomized controlled trial design in which outcomes of MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as usual (TAU). In the pilot study (R21; N=30), we will randomize MMT patients with chronic pain to MORE (n=15) or TAU (n=15). This study phase will focus on establishing study feasibility in recruiting, retaining, and following up study participants before progressing to a larger Phase II clinical trial (R33, N=150). Participants with pain who are receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics in New Jersey.
Participants will be recruited through flyers posted in the clinics, being approached by research assistants in the waiting room of their usual methadone clinic, and referral by clinic staff. The number of individuals who contact the study staff through the flyers or referral and who are approached by study staff in the clinics will be tracked. Number of individuals who refuse study participation and who consent to the study will also be tracked. If an individual is interested in study participation, a trained research assistant will lead the individual through the informed consent process in a private space.
Since MORE is a closed group, we will randomize cohorts of 14-16 participants (depending on speed of recruitment) at each site to TAU or MORE with block randomization. Once we 14-16 participants at a particular clinic, we will randomize participants to MORE or TAU, and the MORE group will begin.
Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions led by a clinic or study counselor. Each session will contain 6-8 participants and take place in a private room at the methadone clinic. Attendance at each session and reasons for missing sessions will be recorded Participants randomized to the control condition will continue receiving treatment as usual.
All study participants will partake in a total of three interviews lasting up to 90 minutes and occurring at baseline, 8- and 16- weeks post-baseline in private rooms in the methadone clinics. Each participant will also have a urine or saliva sample collected during each assessment. All attempts to reach participants to schedule follow-up assessments will be tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones, which will be provided to each participant by study staff. EMA participation will require the participant to respond to twice-daily prompts in which they will be asked a series of brief questions regarding their current mood and exposure to opioid triggers. Additionally, subjects will be asked to initiate responses when they experience serious craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Experimental | Behavioral: Mindfulness Oriented Recovery EnhancementThe Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day. |
| Methadone program behavioral treatment as usual | Other | Behavioral: Methadone program behavioral treatment as usualIn the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- English-speaking
- Been in methadone treatment for at least 3 months
- Experience a non-malignant pain (with an intensity level of 8 or higher on the Gracely Box Scale) for a duration of 2 months or longer.
Key exclusion criteria (6 listed)
- Exhibit cognitive impairment (score <24 on the Mini Mental Status Exam)
- Exhibit psychosis (positive SCID Psychotic Screen),
- Are at suicidal risk (positive score on ASQ Suicide Risk Screening Tool)
- Unable to attend group sessions due to distance, work, commitments or other logistical problems,
- Are currently pregnant or breastfeeding
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 |
|---|---|---|
| Mindfulness Oriented Recovery EnhancementAlso: MOREMORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day. | Behavioural | Mindfulness Oriented Recovery Enhancement |
| Methadone program behavioral treatment as usualAlso: Treatment as Usual, TAUIn the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups. | Behavioural | Methadone program behavioral treatment as usual |
Primary outcome
Study Interest
Time frame: Baseline
The number of individuals who express interest in the study.
Study Refusal
Time frame: Baseline
The number of individuals who who refuse participation when offered.
Individuals Screened
Time frame: Baseline (study enrollment)
The number of individuals screened and eligible/ineligible.
Individuals Consented.
Time frame: Baseline (study enrollment)
The number of individuals consented.
Refusal After/During Consent Process.
Time frame: Enrollment
The number of individuals who refuse participation after/during consent process.
Mean Sessions Completed
Time frame: At 8-weeks (post treatment period completion).
The mean number of sessions completed by study participants in the MORE intervention.
Percentage of Sessions Completed
Time frame: At 8-weeks (post treatment period completion).
The mean percentage of sessions completed by study participants randomized to MORE.
Number Who Drop Out
Time frame: At 16 weeks.
Number of participants who drop out of the study.
Percentage Who Drop Out
Time frame: At 16 weeks.
Percentage of participants who drop out of the study.
Baselines Completed
Time frame: At baseline,
The number of participants who complete baseline assessments.
Percentage Baselines Completed
Time frame: At baseline,
Percentage of people who completed baseline assessments.
8-weeks Completed
Time frame: At 8-weeks.
The number of participants who complete 8-week assessments.
Percentage 8-Weeks Completed
Time frame: At 8-weeks.
Percentage of participants who completed 8-week assessments.
16-Weeks Completed
Time frame: At 16-weeks.
The number of participants who completed 16-week assessments.
Percentage of 16-Weeks Completed
Time frame: At 16-weeks.
Percentage of participants who completed 16-week assessments.
6 secondary outcomes
Days of Illicit Drug Use
Time frame: 16-weeks
Days of Illicit Opioid Use
Time frame: 16-weeks
Opioid Craving
Time frame: 16-weeks
Pain Level.
Time frame: 16-weeks
Depression Level.
Time frame: 16-weeks
Anxiety Level.
Time frame: 16-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31404850Garland EL, Hanley AW, Kline A, Cooperman NA. Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. Drug Alcohol Depend. 2019 Oct 1;203:61-65. doi: 10.1016/j.drugalcdep.2019.07.007. Epub 2019 Aug 5.
- Individual participant dataSharing planned: Yes. Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 30 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.
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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.
Nina A Cooperman, PsyD principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Oriented Recovery Enhancement and Methadone program behavioral treatment as usual in people with Opioid Use and Chronic Pain, run by Rutgers, The State University of New Jersey 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 4 inclusion and 6 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 11 Jan 2022. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Study Interest (time frame: Baseline). The study lists 15 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 NCT03894501, 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 11 Jan 2022.