The subjective psychoactive effects of oral dronabinol studied in a randomized, controlled crossover clinical trial for pain.
Mohammed A Issa, Sanjeet Narang, Robert N. Jamison, Edward Michna, Robert R Edwards, David M Penetar, Ajay D. Wasan
Clinical Journal of Pain June 2014 DOI: 10.1097/ajp.0000000000000022 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 30 |
| Population | Chronic noncancer pain patients taking opioids and not using marijuana; comparison sample of 20 participants with no pain |
| Intervention | Dronabinol |
| Dose | 10 or 20 mg single dose |
| Duration | 8 hours of hourly monitoring per session; 3 sessions |
| Measures | Addiction Research Center Inventory (ARCI) |
| Key findings | Single doses of 10 and 20 mg oral dronabinol produced significantly elevated scores on 4 of 5 ARCI subscales versus placebo in chronic pain patients, with peak effects at 2 hours comparable to peak effects of smoked marijuana at 30 minutes. The authors argue this psychoactive risk must be considered when prescribing cannabinoid medications for pain. |
Abstract
Many cannabinoid medications are approved in North America or in phase III trials, such as dronabinol, nabilone, or nabiximols. Little is known about their subjective psychoactive effects when used for pain management. We hypothesized that when used for pain, dronabinol has psychoactive effects in a dose-response relationship, whose peak effects are comparable with smoking marijuana. This was a randomized controlled trial of single dose placebo, 10 or 20 mg dronabinol in 30 chronic noncancer pain patients taking opioids and not using marijuana. Participants completed the Addiction Research Center Inventory (ARCI) hourly for 8 hours during 3 monitored sessions. Comparison sample was the ARCI ratings in participants with no pain (N=20), monitored every 30 minutes after smoking a 1.99% THC (low) and a 3.51% (high strength) marijuana cigarette. The 10 and 20 mg dronabinol doses had significantly elevated scores over time on 4/5 subscales versus placebo (P<0.05). Average daily morphine use, total pain relief (TOTPAR), age, sex, and baseline pain level were not significant covariates. ARCI peak effects at 2 hours were similar to peak effects of smoked marijuana at 30 minutes (P=0.80, 10 mg=low strength, 20 mg=high strength). In pain patients, oral dronabinol has similar psychoactive effects to smoking marijuana. This risk must be considered in any decision to prescribe cannabinoid medications for pain.