Adults 18 to 70, any sex, with Addiction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Agitation Calmness Evaluation Scale (ACES)Primary· Baseline (30 minutes before the administration of CBD), hourly for 4 hours after the administration of methadone (administered +210 minutes after CBD) and 3 hours after the administration of buprenorphine (administered +210 minutes after CBD)
The ACES consists of a single item that rates overall agitation and sedation of the participant at the time of evaluation, where 1 indicates marked agitation; 2: moderate agitation; 3: mild agitation; 4: normal behavior; 5: mild calmness; 6: moderate calmness; 7: marked calmness; 8: deep sleep; and 9: unarousable. Clinically significant sedation was a priori defined as an ACES score of 7 (marked calmness) or higher at any point during the session. A score was averaged across all time intervals.
Baseline (-30 Minutes)
Group
Value
95% CI
CBD 400mg
4
± 0
CBD 800mg
4
± 0
CBD 1200mg
4
± 0
+270 Minutes
Group
Value
95% CI
CBD 400mg
4.07
± 0.40
CBD 800mg
4
± 0
CBD 1200mg
4.01
± 0.11
+330 Minutes
Group
Value
95% CI
CBD 400mg
4.02
± 0.24
CBD 800mg
4
± 0
CBD 1200mg
4
± 0
+390 Minutes
Group
Value
95% CI
CBD 400mg
4
± 0
CBD 800mg
4
± 0
CBD 1200mg
4
± 0
+450 Minutes
Group
Value
95% CI
CBD 400mg
4
± 0
CBD 800mg
4
± 0
CBD 1200mg
4
± 0
Mini Mental Status Examination (MMSE)Primary· Baseline (30 minutes before the administration of CBD), hourly for 4 hours after the administration of methadone (administered +210 after CBD) and 3 hours after the administration of buprenorphine (administered +210 minutes after CBD)
The MMSE is a 30-point scale ranging from 0 to 30 that measures five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Each scale is summed to compute a total score. The MMSE is used extensively in clinical and research settings to measure cognitive impairment. A score of 24 or higher is generally considered within the normal range, while lower scores suggest potential cognitive impairment. Scores are often interpreted as follows: 25-30 = normal cognition, 21-24 = mild impairment, 10-20 = moderate impairment, and below 10 = severe impairme
Baseline (-30 minutes)
Group
Value
95% CI
CBD 400mg
29.43
± 0.98
CBD 800mg
29.33
± 1.21
CBD 1200mg
29.50
± 0.55
+270 Minutes
Group
Value
95% CI
CBD 400mg
29.86
± 0.38
CBD 800mg
29.33
± 0.82
CBD 1200mg
29.83
± 0.41
+330 Minutes
Group
Value
95% CI
CBD 400mg
29.57
± 0.79
CBD 800mg
29.57
± 0.53
CBD 1200mg
29.14
± 1.46
+390 Minutes
Group
Value
95% CI
CBD 400mg
30
± 0
CBD 800mg
29.33
± 1.03
CBD 1200mg
29.43
± 0.53
+450 Minutes
Group
Value
95% CI
CBD 400mg
29.50
± 0.58
CBD 800mg
29.50
± 0.58
CBD 1200mg
29.67
± 0.58
Systematic Assessment of Side Effects (SAFTEE)Primary· baseline and 4.5 hours after the administration of CBD
The SAFTEE is a multi-symptom checklist that has been used successfully in our previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE was administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4.5 hours after the administration of CBD (timepoint +240 minutes) during each test session. Data presented here is the n
Group
Value
95% CI
CBD 400mg
5
CBD 800mg
5
CBD 1200mg
5
Quantitative Sensory Testing (QST)- Threshold and ToleranceSecondary· baseline, 2 hours and 4 hours after the administration of CBD.
Pain threshold and tolerance will be assessed using a comprehensive QST battery. This is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience. QST measures are sensitive to the effects of cannabinoids, important biomarkers of chronic pain, and predictors of the pain treatment response. Threshold: the temperature the participant first begins to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. A lower temperature repre
Threshold Baseline
Group
Value
95% CI
CBD 400mg
40.29
± 5.6
CBD 800mg
40.55
± 4.3
CBD 1200mg
41.435
± 4.36
Threshold 2 hours
Group
Value
95% CI
CBD 400mg
39.65
± 3.85
CBD 800mg
40.47
± 4.27
CBD 1200mg
40.63
± 4.3
Threshold 4 hours
Group
Value
95% CI
CBD 400mg
39.95
± 3.99
CBD 800mg
40.47
± 3.9
CBD 1200mg
39.94
± 4.33
Tolerance Baseline
Group
Value
95% CI
CBD 400mg
46.17
± 3.57
CBD 800mg
46.33
± 3.4
CBD 1200mg
47.08
± 2.76
Tolerance 2 hours
Group
Value
95% CI
CBD 400mg
46.70
± 2.66
CBD 800mg
45.82
± 3.9
CBD 1200mg
45.07
± 4.35
Tolerance 4 hours
Group
Value
95% CI
CBD 400mg
45.74
± 3.62
CBD 800mg
46.66
± 2.86
CBD 1200mg
45.81
± 3.88
Change in Quantitative Sensory Testing (QST) Conditioned Pain Modulation (CPM)Secondary· Baseline (-30 minutes), 2 hours (+120 minutes), and 4 hours (+240 minutes) after the administration of CBD.
CPM indexes top-down pain inhibition, by leveraging the "pain inhibits pain phenomena". In CPM, a test stimulus is rated on a -100 to +100 Numeric Rating Scale (NRS) for pain both alone and during a concurrent conditioning stimulus applied elsewhere on the body. The CPM Score is the difference between these two ratings.
CPM score is a Difference (Delta): Pain rating (test stimulus alone) - Pain rating (test stimulus with conditioning stimulus) Interpretation: Higher (more positive) values indicate greater pain inhibition.
Baseline (-30 Minutes)
Group
Value
95% CI
CBD 400mg
3.43
± 11.69
CBD 800mg
5.29
± 12.4
CBD 1200mg
5.7
± 5.6
+120 Minutes
Group
Value
95% CI
CBD 400mg
2.14
± 5.81
CBD 800mg
-4.28
± 6.21
CBD 1200mg
1.71
± 2.98
+240 Minutes
Group
Value
95% CI
CBD 400mg
-9.86
± 22.99
CBD 800mg
-6.28
± 10.17
CBD 1200mg
-4.42
± 11.88
Quantitative Sensory Testing (QST) Temporal Summation of Pain (TSP)Secondary· Baseline, 2 hours and 4 hours after the administration of CBD.
Pain will be assessed using a comprehensive QST battery. QST measures are sensitive to the effects of cannabinoids, important biomarkers of chronic pain, and predictors of the pain treatment response. TSP involves the repeated administration of noxious stimuli, indexing bottom-up pain facilitation. Therefore, TSP measures the increase in pain perception with repeated noxious stimuli, calculated as the area under the curve (AUC) of pain ratings over time during repeated stimulation.
Higher TSP scores indicate worse outcomes (greater pain facilitation/central sensitization), while lower TSP sco
Baseline (-30 Minutes)
Group
Value
95% CI
CBD 400mg
522436.5
± 784227.4
CBD 800mg
333689.75
± 596722.19
CBD 1200mg
337314.16
± 641890.80
+120 Minutes
Group
Value
95% CI
CBD 400mg
549573
± 841674.11
CBD 800mg
354263.75
± 693645.10
CBD 1200mg
390454.3
± 670332.51
+240 Minutes
Group
Value
95% CI
CBD 400mg
445697.91
± 697669.30
CBD 800mg
260961.4
± 399847.43
CBD 1200mg
542224.7
± 731050.04
Change in The Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)Secondary· Average difference of scores from before cue-induced craving video (+150 minutes) and after cue-induced craving video (+155 minutes)
The Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14) consists of 14 statements about the respondent's feelings and thoughts about using heroin as he or she is completing the questionnaire (i.e., right now). Each of the 14 items is scored on a scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The HCQ-SF-14 score is obtained by adding the scores of all 14 statements and dividing the total by 14. Higher scores on the HCQ-SF-14 indicate a stronger craving for heroin.
The HCQ-14 was administered before (+150 minutes) and after (+155 minutes) participants watched a cue-induced craving
Group
Value
95% CI
CBD 400mg
-0.57
± 3.05
CBD 800mg
-0.56
± 3.69
CBD 1200mg
0.33
± 2.58
Adverse events — posted to ClinicalTrials.gov
Time frame: baseline up to 6 hours post CBD.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CBD 400mg
Serious: 0/7 (0%)
Deaths: 0/7
CBD 800mg
Serious: 0/7 (0%)
Deaths: 0/7
CBD 1200mg
Serious: 1/7 (14%)
Deaths: 0/7
Serious adverse events (1 terms)
Reaction
System
CBD 400mg
CBD 800mg
CBD 1200mg
Unrelated Serious Adverse Event
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving methadone or buprenorphine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 26 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05076370.