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Dronabinol for Chronic Low Back Pain (DARP Trial)

Phase 2
Recruiting
Led By Christopher D Verrico, phD
Research Sponsored by Christopher D. Verrico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to take oral medication per protocol
Has chronic low back pain that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
Must not have
Current and unwilling to stop use of cannabis/marijuana and any other cannabinoids, including over the counter CBD products
Known allergic reactions to cannabis, CBD, THC, or components of the study interventions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8-weeks

Summary

This trial aims to investigate the use of Marinol (synthetic THC) for chronic low back pain. It will involve 75 participants who will be randomly assigned to receive either THC or a placebo over

Who is the study for?
This trial is for adults with chronic low back pain or a back injury. Participants must be willing to take oral medication and be available for the full 8-week study period. People who are pregnant, breastfeeding, have certain mental health conditions, or use substances that could interact with THC are not eligible.
What is being tested?
The trial is testing Dronabinol (synthetic THC) against a placebo to see if it can help reduce chronic lower back pain. Participants will either receive up to 30 mg/day of Dronabinol or a placebo over an 8-week period in a blinded study where neither they nor the investigators know who's receiving the actual drug.
What are the potential side effects?
Possible side effects of Dronabinol may include dizziness, dry mouth, altered mental state, mood changes, increased heart rate, and digestive issues. Since this is exploratory research, part of the study's purpose is to gather more information on potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills as directed.
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I have had chronic low back pain for at least 3 months.
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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently use cannabis or CBD products and do not want to stop.
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I am not allergic to cannabis, CBD, THC, or related substances.
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I have not had any pain treatments in the last 6 weeks.
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I am currently taking medication for epilepsy.
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I have a device implanted for pain management in my spine.
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I have a history of or am currently experiencing thoughts of suicide.
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I have a history of seizures.
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I have a history of heart problems.
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I am currently using medications such as sleeping pills, anxiety medication, or muscle relaxants.
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I have not had surgery or needed more pain medicine since joining the study.
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I do not have any untreated infectious diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Intensity
Safety Analysis - Adverse Events (AEs)
Secondary study objectives
Analgesic Use Log
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Profile of Mood States (POMS questionnaire)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: DronabinolExperimental Treatment1 Intervention
Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080

Find a Location

Who is running the clinical trial?

Christopher D. VerricoLead Sponsor
1 Previous Clinical Trials
44 Total Patients Enrolled
Christopher D Verrico, phDPrincipal InvestigatorBaylor College of Medicine
~50 spots leftby Dec 2026
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