MindfulnessPhase 1NCT06642181
Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
A Phase 1 study testing Guanfacine pharmacotherapy and Mindfulness Oriented Recovery Enhancement (MORE) in people with Mindfulness and Guanfacine, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mindfulness, Guanfacine, Opioid Use Disorder
- What is being tested?
- Guanfacine pharmacotherapy and Mindfulness Oriented Recovery Enhancement (MORE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 30 Sep 2026
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- N=224 individuals with a history of SCID-5 OUD, and maintained on BUP for at least 4 weeks (N=80 in the R61 phase and N=144 in the R33 phase). These individuals must be:
- aged 18 to 55 years and have a body mass index (BMI) of 18-35;
- have a positive urine toxicology screen for non-prescription opioids
- be in good health as verified by screening examination
- able to read English and provide informed consent.
Who cannot join
- Current SCID V criteria for a moderate to severe substance use disorder other than opioids or nicotine (although mild use will be permitted)
- Use of medications in the last 6 months that may affect cerebral function with the exception of BUP and individuals stabilized on SSRIs
- psychotic or severely psychiatrically disabled (i.e. suicidal, current mania)
- hypotensive individuals with sitting blood pressure below 100/50 mmHG
- Women who are pregnant, nursing or refuse to use a reliable form of birth control
- EKG evidence at baseline screening of any clinically significant conduction abnormalities (Bazett's QTc of >450 msec for men and QTc>470 msec for women)
- R33 phase will additionally include failure to satisfy fMRI safety protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers School of Health Professions
Newark, New Jersey, 07107
Suchismita Ray, PhD, 732-266-4553, shmita@rutgers.edu
About this study
The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. This may be due to the fact that they do not fully engage the neural processes sub-serving the emotional control of sensitized negative mood and reward sensitivity during stress- and opioid-cue provocation, respectively. In contrast while the alpha2 agonist, guanfacine, may attenuate stress-provoked opioid craving by mediating top-down prefrontal control over sensitized dysphoria, the behavioral intervention, Mindfulness Oriented Recovery Enhancement (MORE) may reduce opioid cue-provoked craving by mediating top-down prefrontal control over hedonic dysregulation. Furthermore, while both interventions separately may prove effective as longer-term adjunctive therapies, they may offer greater efficacy together, providing a unique medication/behavioral combination able to target both stress and reward provocation mechanisms. To optimally test this hypothesis, a staged approach is proposed to first confirm the efficacy of both GXR and MORE, independently and combined (R61), prior to elucidating underlying neural mechanisms (R33). Using a 2 X 2 design, N=80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release (GXR; 3mgs, n=40) or placebo (PBO; n=40). Half of all participants in each group will then receive either weekly MORE, or a Support Group (SG) control, creating four intervention groups (Control Grp: PBO+SG, n=20); (GXR Grp: GXR+SG, n=20); (MORE Grp: PBO+ MORE, n=20); (Combined Grp: GXR+MORE, n=20). A pre- and post-laboratory study will be conducted before and after six weeks of intervention where participants will be randomly exposed to 3 personalized guided imageries (stress, opioid cue, neutral). Subjective measures of opioid craving, anxiety, mood, stress, emotional reappraisal, and heart rate will be collected before and after imagery exposure. Following milestone completion, an identical design is proposed in N=144 individuals, where participants will be exposed to imageries in the MRI scanner (R33). On the basis of prior research, it is hypothesized in that GXR will attenuate opioid craving and improve emotion regulation during stress, while MORE will demonstrate the same effects during opioid cue exposure. Combined GXR and MORE will also demonstrate additive or synergistic improvements compared with each intervention alone (R61). The effects of GXR on opioid cue- and MORE on stress-provoked opioid seeking will be explored. In the R33 component, it is hypothesized that GXR will improve regulatory and affective brain function during stress, and MORE will improve regulatory and reward function during opioid cue exposure. Combined GXR and MORE may improve regulatory function in an additive or synergistic manner (R33). Findings will help elucidate the efficacy and neural mechanisms underpinning a novel integrated pharmaco-behavioral therapy for OUD individuals maintained on BUP.
- Conditions
- Mindfulness, Guanfacine, Opioid Use Disorder
- Being tested
- Guanfacine pharmacotherapy, Mindfulness Oriented Recovery Enhancement (MORE)
- Keywords
- Opioid, MIndfulness, Guanfacine
- 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.
Guanfacine pharmacotherapyDrug
It is a pharmacotherapy
Mindfulness Oriented Recovery Enhancement (MORE)Behavioural
It is a mindfulness intervention
| Study group | Role | What they receive |
|---|---|---|
| Combined Group | Experimental | Will receive both Guanfacine pharmacotherapy and MORE intervention Receives: Drug: Guanfacine pharmacotherapy; Behavioral: Mindfulness Oriented Recovery Enhancement (MORE) |
| MORE Group | Experimental | Will receive MORE intervention and placebo medication Receives: Behavioral: Mindfulness Oriented Recovery Enhancement (MORE) |
| Guanfacine Group | Experimental | Will receive Guanfacine intervention and Support group control (non-mindfulness) intervention Receives: Drug: Guanfacine pharmacotherapy |
| Control Group | No intervention | Will receive placebo and support group control (non-mindfulness) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
Self report of opioid craving will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme).
Measured: At pre- and post-intervention (6 weeks intervention)
Anxiety
Self report of anxiety will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme). .
Measured: At pre- and post-intervention (6 weeks intervention)
Stress
Self report of stress will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme).
Measured: At pre- and post-intervention (6 weeks intervention)
Mood
Self report of mood will be collected. Positive and negative mood will be collected on a 4 point likert scale 0 (not at all) and 4 (extreme)
Measured: At pre- and post-intervention (6 weeks intervention)
Emotional Dysregulation
Self report of emotional dysregulation data will be collected. Will be measured using a 10 point likert scale (0=not at all) and 10 (extreme)
Measured: At pre- and post-intervention (6 weeks intervention)
Heart Rate
Heart rate data will be collected using an EKG monitor during the entire lab procedure while the participants will hear stress, opioid, and neutral related scripts.
Measured: At pre- and post-intervention (6 weeks intervention)
Brain Activation
Brain activation data will be collected using Blood Oxygen Level Dependent (BOLD) signal during functional magnetic resonance imaging (fMRI) while participants hear stress, opioid and neutral scripts.
Measured: At pre- and post-intervention (6 weeks intervention)
Brain Connectivity
Brain connectivity data will be collected using Blood Oxygen Level Dependent (BOLD) signal during functional magnetic resonance imaging (fMRI) while participants hear stress, opioid and neutral scripts.
Measured: At pre- and post-intervention (6 weeks intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Jul 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Suchismita Ray Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642181
- Sponsor's protocol ID
- Pro2024002125
- Other IDs
- 1R61DA059906-01A1
- Status last verified
- Aug 2025
- First submitted
- 9 Oct 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06642181
- Acronym / sponsor ID
- Pro2024002125
- Conditions
- Mindfulness, Guanfacine, Opioid Use Disorder
- Keywords
- Opioid, MIndfulness, Guanfacine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. This may be due to the fact that they do not fully engage the neural processes sub-serving the emotional control of sensitized negative mood and reward sensitivity during stress- and opioid-cue provocation, respectively. In contrast while the alpha2 agonist, guanfacine, may attenuate stress-provoked opioid craving by mediating top-down prefrontal control over sensitized dysphoria, the behavioral intervention, Mindfulness Oriented Recovery Enhancement (MORE) may reduce opioid cue-provoked craving by mediating top-down prefrontal control over hedonic dysregulation. Furthermore, while both interventions separately may prove effective as longer-term adjunctive therapies, they may offer greater efficacy together, providing a unique medication/behavioral combination able to target both stress and reward provocation mechanisms. To optimally test this hypothesis, a staged approach is proposed to first confirm the efficacy of both GXR and MORE, independently and combined (R61), prior to elucidating underlying neural mechanisms (R33). Using a 2 X 2 design, N=80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release (GXR; 3mgs, n=40) or placebo (PBO; n=40). Half of all participants in each group will then receive either weekly MORE, or a Support Group (SG) control, creating four intervention groups (Control Grp: PBO+SG, n=20); (GXR Grp: GXR+SG, n=20); (MORE Grp: PBO+ MORE, n=20); (Combined Grp: GXR+MORE, n=20). A pre- and post-laboratory study will be conducted before and after six weeks of intervention where participants will be randomly exposed to 3 personalized guided imageries (stress, opioid cue, neutral). Subjective measures of opioid craving, anxiety, mood, stress, emotional reappraisal, and heart rate will be collected before and after imagery exposure. Following milestone completion, an identical design is proposed in N=144 individuals, where participants will be exposed to imageries in the MRI scanner (R33). On the basis of prior research, it is hypothesized in that GXR will attenuate opioid craving and improve emotion regulation during stress, while MORE will demonstrate the same effects during opioid cue exposure. Combined GXR and MORE will also demonstrate additive or synergistic improvements compared with each intervention alone (R61). The effects of GXR on opioid cue- and MORE on stress-provoked opioid seeking will be explored. In the R33 component, it is hypothesized that GXR will improve regulatory and affective brain function during stress, and MORE will improve regulatory and reward function during opioid cue exposure. Combined GXR and MORE may improve regulatory function in an additive or synergistic manner (R33). Findings will help elucidate the efficacy and neural mechanisms underpinning a novel integrated pharmaco-behavioral therapy for OUD individuals maintained on BUP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined Group | Experimental | Drug: Guanfacine pharmacotherapy, Behavioral: Mindfulness Oriented Recovery Enhancement (MORE)Will receive both Guanfacine pharmacotherapy and MORE intervention |
| MORE Group | Experimental | Behavioral: Mindfulness Oriented Recovery Enhancement (MORE)Will receive MORE intervention and placebo medication |
| Guanfacine Group | Experimental | Drug: Guanfacine pharmacotherapyWill receive Guanfacine intervention and Support group control (non-mindfulness) intervention |
| Control Group | No intervention | –Will receive placebo and support group control (non-mindfulness) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- N=224 individuals with a history of SCID-5 OUD, and maintained on BUP for at least 4 weeks (N=80 in the R61 phase and N=144 in the R33 phase). These individuals must be:
- aged 18 to 55 years and have a body mass index (BMI) of 18-35;
- have a positive urine toxicology screen for non-prescription opioids
- be in good health as verified by screening examination
- able to read English and provide informed consent.
Key exclusion criteria (7 listed)
- Current SCID V criteria for a moderate to severe substance use disorder other than opioids or nicotine (although mild use will be permitted)
- Use of medications in the last 6 months that may affect cerebral function with the exception of BUP and individuals stabilized on SSRIs
- psychotic or severely psychiatrically disabled (i.e. suicidal, current mania)
- hypotensive individuals with sitting blood pressure below 100/50 mmHG
- Women who are pregnant, nursing or refuse to use a reliable form of birth control
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 |
|---|---|---|
| Guanfacine pharmacotherapyIt is a pharmacotherapy | Drug | Combined Group, Guanfacine Group |
| Mindfulness Oriented Recovery Enhancement (MORE)It is a mindfulness intervention | Behavioural | Combined Group, MORE Group |
Primary outcome
Craving
Time frame: At pre- and post-intervention (6 weeks intervention)
Self report of opioid craving will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme).
Anxiety
Time frame: At pre- and post-intervention (6 weeks intervention)
Self report of anxiety will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme). .
Stress
Time frame: At pre- and post-intervention (6 weeks intervention)
Self report of stress will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme).
Mood
Time frame: At pre- and post-intervention (6 weeks intervention)
Self report of mood will be collected. Positive and negative mood will be collected on a 4 point likert scale 0 (not at all) and 4 (extreme)
Emotional Dysregulation
Time frame: At pre- and post-intervention (6 weeks intervention)
Self report of emotional dysregulation data will be collected. Will be measured using a 10 point likert scale (0=not at all) and 10 (extreme)
Heart Rate
Time frame: At pre- and post-intervention (6 weeks intervention)
Heart rate data will be collected using an EKG monitor during the entire lab procedure while the participants will hear stress, opioid, and neutral related scripts.
Brain Activation
Time frame: At pre- and post-intervention (6 weeks intervention)
Brain activation data will be collected using Blood Oxygen Level Dependent (BOLD) signal during functional magnetic resonance imaging (fMRI) while participants hear stress, opioid and neutral scripts.
Brain Connectivity
Time frame: At pre- and post-intervention (6 weeks intervention)
Brain connectivity data will be collected using Blood Oxygen Level Dependent (BOLD) signal during functional magnetic resonance imaging (fMRI) while participants hear stress, opioid and neutral scripts.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Guanfacine pharmacotherapy and Mindfulness Oriented Recovery Enhancement (MORE) in people with Mindfulness and Guanfacine, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Suchismita Ray, PhD (732-266-4553, shmita@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving (time frame: At pre- and post-intervention (6 weeks intervention)). The study lists 8 primary outcomes in all. 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 8 Aug 2025.