Effects of Dronabinol in Opioid Maintained Patients
Status:
Recruiting
Trial end date:
2022-01-30
Target enrollment:
Participant gender:
Summary
Twenty male and female (ages 18-60) participants with OUD currently receiving methadone or
buprenorphine will be enrolled. Prior to their daily methadone or buprenorphine dose and thus
at trough plasma levels of opioid, participants will receive dronabinol (10, 20mg) or
placebo. Subsequently, all participants will undergo laboratory testing of opioid-related
outcomes. Pain sensitivity will be measured using the well-validated Cold Pressor Test (CPT),
the Short-Form McGill Pain Questionnaire (SF-MPQ) and a pain Visual Analog Scale (VAS).
Attentional bias will be measured using a visual probe task. Negative affect will be measured
using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be
measured by a comprehensive cognitive battery. The order of study medication administration
will be counterbalanced order to minimize carryover effects. On the initial screening day and
at the end of medication treatment, blood will be drawn to determine serum cytokine levels.
One week after the last study medication dose, a follow-up session will be conducted during
which participants will undergo urine toxicology testing and a safety evaluation before final
discharge from the study.