An interventional study of Cannabis and Prescription Opioid Taper Support (POTS) in Opioid Use, Pain and Marijuana Use, sponsored by Massachusetts General Hospital. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).
This trial is a randomized, six-month study of cannabis (CB) on opioid use that will: (1) evaluate whether adults with chronic, non-cancer pain on COT assigned to CB, compared with those assigned to a waitlist control condition (WL), have greater reduction in opioid dose and/or pain intensity and interference, (2) assess whether participants assigned to CB, compared with those assigned to WL, have improved quality of life, depression, and anxiety; and reduced self-reported opioid dose, (3) evaluate whether those assigned to CB develop symptoms of CUD and have a reduced number of OUD symptoms over the 24-week intervention, as well as at the 12-month time point.
Participants will be randomly assigned to either an active CB arm (n = 60), or to a waitlist control arm (WL) (n = 60). Participants will be assessed at baseline, every 4 weeks for 6 months, and at a 12-month follow-up for opioid use, development of CUD, development or resolution of OUD, and neurocognitive performance. Urine collected will be assessed with quantitative assays.
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This study's enrollment of 87 is above the median of 70 across 1,904 interventional studies indexed under Pain.
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Exclusion Criteria:
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources. All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
Drug: Cannabis · Behavioral: Prescription Opioid Taper Support (POTS)
Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks. All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.
Behavioral: Prescription Opioid Taper Support (POTS)
Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.
All participants were offered weekly group Prescription Opioid Taper Support (POTS) sessions for 24 weeks. POTS is behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering. This intervention was adapted for this trial to include group-based delivery. Sessions are one hour delivered via teleconference and incorporated cognitive behavioral, mindfulness-based, and motivational interviewing strategies.
Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
Time frame: Week 24
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval
The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Every post-baseline day until week 24
Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval
Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Every post-baseline day until week 24
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24
The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24
The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24
Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in Cannabis Use Disorder Symptoms at Weeks 12 and 24
Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
Time frame: Week 12, Week 24
Recruitment took place at three academic medical centers in the Northeastern United States (Massachusetts General Hospital, Boston, MA; Cambridge Health Alliance, Cambridge, MA; Maine Medical Center, Portland, ME).
| Milestone | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Started | 42 | 45 |
| Completed | 42 | 45 |
| Not completed | 0 | 0 |
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
| MME/day | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24 | 113.3 (84.7 to 141.9) | 97.9 (70.2 to 125.6) |
The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| score | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval | 5.35 (4.98 to 5.73) | 5.30 (4.89 to 5.72) |
Self-reported opioid dose in morphine milligram equivalents (MME) per day. Self-reported opioid dose was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| MME/day | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval | 84.0 (68.4 to 99.6) | 89.6 (71.1 to 108.0) |
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form assesses changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life. Q-LES-SF score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Raw score | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24 | 45.5 (42.9 to 48.0) | 47.3 (44.6 to 49.9) |
The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression. PROMIS-29 depression subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| score | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24 | 52.7 (50.8 to 54.5) | 52.4 (50.5 to 54.3) |
The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety. PROMIS-29 anxiety subscale score was assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| score | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24 | 53.2 (51.2 to 55.3) | 50.1 (48.0 to 52.1) |
Number of opioid use disorder (OUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. As all participants were taking prescribed opioids under the supervision of a clinician, symptom counts exclude tolerance and withdrawal. Number of symptoms range from 0 to 9. A score of 2 or more indicates a current opioid use disorder diagnosis. Number of opioid use disorder symptoms were assessed at weeks 4, 8, 12, 16, 20, and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Number of symptoms | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24 | 1.14 (0.82 to 1.47) | 1.27 (0.93 to 1.61) |
Number of cannabis use disorder (CUD) symptoms present was assessed via the Diagnostic and Statistical Manual- 5th Edition (DSM-V) checklist. Number of symptoms range from 0 to 11. A score of 2 or more indicates a current cannabis use disorder diagnosis. The number of cannabis use disorder symptoms were assessed at weeks 12 and 24. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.
| Number of symptoms | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Mean Difference in Cannabis Use Disorder Symptoms at Weeks 12 and 24 | 0.54 (0.36 to 0.72) | 0.03 (-0.13 to 0.19) |
Collected over From enrollment until end of intervention, up to 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cannabis (CB) | 0/42 (0%) | 7/42 (16.7%) | 36/42 (85.7%) |
| Waitlist (WL) | 0/45 (0%) | 5/45 (11.1%) | 35/45 (77.8%) |
| Event | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Diabetic ketoacidosisMetabolism and nutrition disorders | 1/42 | 0/45 |
| Dog biteInjury, poisoning and procedural complications | 1/42 | 0/45 |
| HospitalizationsSurgical and medical procedures | 1/42 | 1/45 |
| HypotensionVascular disorders | 1/42 | 0/45 |
| Opiate withdrawal symptomsGeneral disorders | 1/42 | 0/45 |
| Osteomyelitis (acute)Infections and infestations | 1/42 | 0/45 |
| Rib fractureInjury, poisoning and procedural complications | 1/42 | 0/45 |
| Transient ischemic attackNervous system disorders | 1/42 | 0/45 |
| Intrathecal Pump InsertionSurgical and medical procedures | 0/42 | 1/45 |
| Abdominal PainGastrointestinal disorders | 0/42 | 1/45 |
| Event | Cannabis (CB) | Waitlist (WL) |
|---|---|---|
| Pain and discomfortGeneral disorders | 13/42 | 16/45 |
| Anxiety symptomsPsychiatric disorders | 12/42 | 4/45 |
| Non-site specific injuriesInjury, poisoning and procedural complications | 11/42 | 4/45 |
| Depressive disordersPsychiatric disorders | 10/42 | 10/45 |
| Musculoskeletal and connective tissue pain and discomfortMusculoskeletal and connective tissue disorders | 8/42 | 9/45 |
| Analgesia supportive careSurgical and medical procedures | 6/42 | 5/45 |
| General signs and symptomsGeneral disorders | 6/42 | 5/45 |
| Withdrawal and rebound effectsGeneral disorders | 6/42 | 4/45 |
| Dental and gingival therapeutic proceduresSurgical and medical procedures | 0/42 | 6/45 |
| Emotional and mood disturbancesPsychiatric disorders | 5/42 | 0/45 |
| Age, Continuous(Years) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| Mean | 56.4 ± 10.6 | 57.6 ± 9.9 | 57.1 ± 10.2 |
| Sex: Female, Male(Participants) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| Female | 27 | 27 | 54 |
| Male | 15 | 18 | 33 |
| Race (NIH/OMB)(Participants) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 39 | 36 | 75 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 39 | 41 | 80 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Prescription Monitoring Program-verified daily opioid dose(Morphine milligram equivalents (MME)/day) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| Mean | 96.8 ± 113 | 99.7 ± 120.6 | 98.3 ± 116 |
| Opioid use disorder (OUD) symptoms(Number of symptoms) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| Mean | 1.6 ± 1.5 | 1.5 ± 1.4 | 1.5 ± 1.4 |
| Pain, Enjoyment, and General Activity (PEG) Scale Score(Score) | Cannabis (CB) | Waitlist (WL) | Total |
|---|---|---|---|
| Mean | 5.68 ± 1.82 | 5.66 ± 1.95 | 5.67 ± 1.87 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All data, code, and materials used in the analyses can be provided by Jodi Gilman and Massachusetts General Hospital pending scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Requests for all materials should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu.
Supporting information: Study protocol, Sap, Icf, Analytic code
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