Health TrialsbyHealthPanel

Dronabinol as an Adjunct for Reducing Pain

ConditionsLow Back PainChronic PainBack Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorChristopher D. Verrico

About this trial

This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Ability to take oral medication per protocol.

Male or female, aged 18-64 years.

Disqualifiers

Non-English speaking or inability to read and understand English.

Current and unwilling to stop the use of cannabis/marijuana and any other cannabinoids, including over the counter CBD products.

Reported allergic reactions to cannabis, CBD, THC, or components of the study interventions.

Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dronabinol

    Drug

    Eligible subjects will be randomized (2:1) to dronabinol or placebo, administered orally. The dose of dronabinol will be titrated such that on Day 1, subjects will take 2.5 mg, twice. On subsequent days patients may gradually increase the total number of doses, by one dose each day, as needed and tolerated until either the optimal dose is achieved, or the dose reaches 30 mg THC per day.

  • Placebo

    Drug

    Matching placebo will be prepared and administered in the same manner as the active medication. Titration will occur in a masked fashion such that individuals assigned to placebo undergo a similar perceived titration process.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Drug: DronabinolExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity

For change in pain intensity from baseline to 8-weeks, the investigators will estimate the mean within each arm using the Research Standards for Chronic Low-Back Pain (RScLBP).

Time frame
Baseline to 8-weeks
2

Safety Analysis - Adverse Events (AEs)

AEs will be coded using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms and will be grouped by system, organ, and class (SOC) designation. The severity, frequency, and relationship of AEs to investigational product will be presented by preferred term by SOC grouping. Listings of each individual AE including start date, stop date, severity, relationship, outcome, and duration will be provided.

Time frame
Baseline to 8-weeks

Secondary outcomes

1

Analgesic Use Log

Analgesic Use Change in Analgesic Use Log scores Day 1 to 56 Secondary analyses will use proper tests and appropriate statistical methods at a significance level of 0.05 (2-sided).

Time frame
Baseline to 8-weeks
2

Patient-Reported Outcomes Measurement Information System (PROMIS-29)

The severity of pain will be assessed by the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS).

Time frame
Baseline to 8-weeks
3

Profile of Mood States (POMS questionnaire)

Changes in POMS . Scale range is 1 to 5 and describes how you feel right now. Scale of 1, the lowest score, describes a feeling of Not At All right now for the mood and the scale of 5 gives the highest score representing a feeling of Extremely for the mood.

Time frame
Baseline to 8-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christopher D. Verrico

Lead sponsor

Baylor College of Medicine

Sponsor institution

Source ClinicalTrials.gov
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