CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Placebos +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02460692
NCT02460692Phase 2Completed
CompareCT.gov

A Randomized Controlled Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain

University of California, San Diego·interventional·Posted Jun 2, 2015·Updated Sep 28, 2023

In Brief

A Phase 2 clinical trial evaluating Placebos, dronabinol, and 1 other intervention for Cannabis and 2 related conditions. Completed, enrolled 131 participants across 1 site.

Detailed Summary

This study will involve treating low back pain associated with nerve injury with oral delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol and vaporized 3.7% Δ9-THC/5.6% CBD .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCannabis, Low Back Pain, Neuropathic Pain
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartDec 1, 2016
Primary CompletionMar 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.1 years ago

Interventions

Placebosdrug

Administration of vaporized cannabis plus either dronabinol or placebo pill

dronabinoldrug

Administration of vaporized cannabis plus either dronabinol or placebo pill

Vaporized Cannabis 3.7% THC/5.6% CBDdrug

Administration of vaporized cannabis plus either dronabinol or placebo pill