Cannabidiol in Opioid Use Disorder and Chronic Pain With Buprenorphine

Browse trials for

• Chronic Pain 2,998
• Opioid-Related Disorders 1,439
• Pain 2,450

Keywords

• Buprenorphine
• Cannabidiol
• Pain

Chronic Pain

2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's planned enrollment of 34 is below the median of 60 across 2,209 interventional studies indexed under Chronic Pain.

Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

Study arms

• Active comparator
  CBD 400 mg

  CBD 400 mg

  Drug: 400 mg Cannabidiol

• Active comparator
  CBD 800 mg

  CBD 800mg

  Drug: 800 mg Cannabidiol

• Active comparator
  CBD 1200 mg

  CBD 1200 mg

  Drug: 1200 mg Cannabidiol

• Placebo comparator
  Beta carotene oral solution

  Beta carotene oral solution without CBD

  Drug: Beta carotene oral solution without CBD

Interventions

• Drug400 mg Cannabidiol

  Participants will receive 400 mg CBD

  Also known as: CBD, Epidiolex

• Drug800 mg Cannabidiol

  Participants will receive 800 mg CBD

  Also known as: CBD, Epidiolex

• Drug1200 mg Cannabidiol

  Participants will receive 1200 mg CBD

  Also known as: CBD, Epidiolex

• DrugBeta carotene oral solution without CBD

  Participants will receive beta carotene oral solution without CBD (placebo)

  Also known as: Placebo

Primary outcomes

1. Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE)

   The SAFTEE is a multi-symptom checklist that has been used successfully in the investigators 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 is administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4 hours after the administration of CBD (timepoint +240 minutes) during each test session. Data will be presented as the number of participants that reported symptoms on the SAFTEE.

   Time frame: Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD

2. Abuse potential of CBD measured by the Drug Effects Questionnaire (DEQ)

   The DEQ will be administered to assess the abuse potential of CBD. The DEQ is a 10-item questionnaire used to assess the subjective effects of psychoactive drugs. Each item is a visual analogue scale (VAS) ranging from 0-100. The questionnaire is used to measure whether a subject feels the drug "feels high", likes or dislikes the effects, and whether they want more of the drug. The primary DEQ outcome will be the Stimulatory Effects subscale, obtained by averaging participants responses to the items: "Feel High"; "Feel Stimulated"; and "Feel the Drug Strength".

   Time frame: Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)

3. Cognitive effects of CBD measured by the Hopkins Verbal Learning Test (HVLT)

   The HVLT will be used to assess the cognitive effects of CBD. The primary outcomes will be immediate and delayed recall, which index verbal memory. The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The participant is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The participants' free recall of the list is recorded. The same procedure is repeated for two more trials (immediate recall). After approximately 15 minutes the participant will be asked to recall as many words from the list as they can without the list being re-read to them (delayed recall).

   Time frame: +210 minutes after the administration of CBD

4. Cognitive/psychomotor effects of CBD measured by the Continuous Performance Test (CPT)

   The cognitive/psychomotor effects of CBD will be assessed using the Continuous Performance Test (CPT). CPT is a computerized neuropsychological assessment that measures participants sustained and selective attention. For the CPT, the primary outcome will be the throughput score, which indexes attention/working memory accuracy (i.e. percent of correct responses) and speed (i.e. reaction time).

   Time frame: +210 minutes after the administration of CBD

Secondary outcomes

1. Pain sensitivity measured by Quantitative Sensory Testing (QST) Pain threshold and tolerance

   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). Tolerance: the temperature when the participant can no longer tolerate the stimuli. The temperature ranges from 37° Celsius to 50° Celsius. A lower temperature represents a lower pain threshold/tolerance and a higher temperature represents a higher pain threshold/tolerance.

   Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.

2. Pain sensitivity measured by change in Quantitative Sensory Testing (QST) Conditioned Pain Modulation (CPM)

   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.

   Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.

3. Pain sensitivity measured by Quantitative Sensory Testing (QST) Temporal Summation of Pain (TSP)

   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 scores indicate better outcomes (less pain facilitation/central sensitization). The TSP AUC values represent the cumulative pain experience during repeated stimulation (VAS units\*seconds), where larger values reflect greater temporal summation of pain, which is associated with central nervous system sensitization and chronic pain conditions.

   Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.

4. Response to Quantitative Sensory Testing (QST) battery measured by Pain Visual Analog Scale (VAS)

   The pain VAS will be used by participants as a secondary rating scale for pain severity pain testing. This scale ranges from 0 to 100 and contains of a horizontal line, anchored by verbal descriptors of "no pain" and "pain as bad as it could be". Participants will place a vertical line at the point that best indicates their present pain.

   Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.

5. Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)

   The PCS is a 13-item self-report scale designed to measure negative thoughts and feelings associated with pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time). Total scores range from 0 to 52, with higher scores indicating greater catastrophizing. The PCS contains three subscales: magnification (scores ranging from 0-12), rumination (scores ranging from 0-16), and helplessness (scores ranging from 0-24).

   Time frame: Baseline (30 minutes before the administration of CBD)

6. Opioid craving measured by change in the Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)

   The 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 video. The difference of the two HCQ-14 scores (post - pre) will be used to index cue-elicited craving.

   Time frame: Average difference of scores from before cue-induced craving video (+150 minutes) and after cue-induced craving video (+155 minutes)

7. Opioid craving measured by the Subjective Opiate Withdrawal Scale (SOWS)

   The SOWS is a 16-item, participant-administered questionnaire designed to rate the intensity of opioid withdrawal symptoms. It assesses symptoms on a 0-4 scale ("not at all" to "extremely"), with total scores of 1-10 indicating mild, 11-20 moderate, and 21-30 severe withdrawal.

   Time frame: Baseline (30 minutes before the administration of CBD), +30 minutes, +90 minutes, +150 minutes, +210 minutes, and +240 minutes after the administration of CBD

8. Negative affect measured by the Positive and Negative Affect Schedule (PANAS)

   The PANAS is a 20-item self-report questionnaire listing adjectives relating to Positive Affect (PA) (e.g., excited, inspired) and Negative Affect (NA) (e.g., distressed, afraid). Items are rated on a Likert scale ranging from 1 "Very slightly or not at all" to 5 "extremely". The PANAS yields separate PA and NA scores, each ranging from 10 to 50. Higher PA scores indicate more positive feelings, while higher NA scores indicate more negative feelings. These scores are used to track emotional states over time. The PANAS will be used to measure the effects of CBD on mood.

   Time frame: Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)

Individual participant data

Plan to share: No