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Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain

NCT02460692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2023-09-28

Study results available
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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 .

Conditions

  • Cannabis
  • Low Back Pain
  • Neuropathic Pain

Interventions

DRUG

Placebos

Administration of vaporized cannabis plus either dronabinol or placebo pill

DRUG

dronabinol

Administration of vaporized cannabis plus either dronabinol or placebo pill

DRUG

Vaporized Cannabis 3.7% THC/5.6% CBD

Administration of vaporized cannabis plus either dronabinol or placebo pill

Sponsors & Collaborators

Principal Investigators

  • Thomas D Marcotte, PhD · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02460692 on ClinicalTrials.gov