Opioid-use DisorderNCT04824521
A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
A study testing Mindfulness-Oriented Recovery Enhancement in people with Opioid-use Disorder, run by University of Montana at 1 site in United States.
Trial summary
Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Aug 2023
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must be pregnant.
- Must be able to communicate in English.
- Must have met criteria for opioid use disorder in the past year.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Mindful Pregnancy Study: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.
Read the detailed description
Participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. Participants will also be asked to complete self-report measures before and after each session. The primary aims of this study are as follows.
Aim 1: To adapt the in-person MORE intervention for telehealth delivery. Aim 2: To assess the overall feasibility and acceptability of this telehealth intervention. Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to participants.
- Conditions
- Opioid-use Disorder
- Being tested
- Mindfulness-Oriented Recovery Enhancement
- 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.
Mindfulness-Oriented Recovery EnhancementBehavioural
MORE is a mindfulness-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement via tele-health | Experimental | Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction
Participants will complete the Client Satisfaction Questionnaire.
Measured: 8 weeks
Secondary outcomes (1)
SUD Symptoms - Mini Neuropsychiatric Interview
The Mini Neuropsychiatric Interview is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-V. For this study, we conducted a structured interview with participants to determine the number of symptoms of substance use disorder they had experienced in the past year. After completing eight sessions of Mindfulness-Oriented Recovery Enhancement, we conducted the same interview to learn the number of symptoms of substance use disorder participants had experienced in the past eight weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Oct 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2023
Why it stopped: The protocol is determined to no longer be able to meet study objectives due to failure to enroll participants within the requisite time period.
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.
- Other trials for Opioid-use DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Sarah Reese, University of Montana
- Investigators
- Sarah Reese, Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824521
- Sponsor's protocol ID
- 2-21
- Other IDs
- 5P20GM130418
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2021
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mindful Pregnancy Study: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04824521
- Acronym / sponsor ID
- 2-21
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The protocol is determined to no longer be able to meet study objectives due to failure to enroll participants within the requisite time period.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.
Detailed description
Participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. Participants will also be asked to complete self-report measures before and after each session. The primary aims of this study are as follows.
Aim 1: To adapt the in-person MORE intervention for telehealth delivery. Aim 2: To assess the overall feasibility and acceptability of this telehealth intervention. Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement via tele-health | Experimental | Behavioral: Mindfulness-Oriented Recovery EnhancementParticipants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be pregnant.
- Must be able to communicate in English.
- Must have met criteria for opioid use disorder in the past year.
Key exclusion criteria (1 listed)
- None.
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 EnhancementMORE is a mindfulness-based intervention. | Behavioural | Mindfulness-Oriented Recovery Enhancement via tele-health |
Primary outcome
Client Satisfaction
Time frame: 8 weeks
Participants will complete the Client Satisfaction Questionnaire.
1 secondary outcome
SUD Symptoms - Mini Neuropsychiatric Interview
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah Reese principal investigator
University of Montana
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 in people with Opioid-use Disorder, run by University of Montana 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 1 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: stopped early, as of the sponsor's last update on 16 Jan 2024. 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 16 Jan 2024). 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?
Client Satisfaction (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2024.