Dronabinol as an Adjunct for Reducing Pain

NCT06454669 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: H-51389
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Injuries; Low Back Pain; Chronic Pain

Keywords

dronabinol; Marinol; THC

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline to 8-weeks

• 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.

  Baseline to 8-weeks

Secondary Outcomes (3)

• Analgesic Use Log

  Baseline to 8-weeks

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

  Baseline to 8-weeks

• Profile of Mood States (POMS questionnaire)

  Baseline to 8-weeks

Study Arms (2)

Drug: Dronabinol

EXPERIMENTAL

Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks.

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks.

Drug: Placebo

Interventions

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.

Also known as: Marinol, delta-9-tetrahydrocannabinol

Drug: Dronabinol

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Has chronic low back pain (i.e., in the space between the lower posterior margin of the rib cage and the horizontal gluteal fold) that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months (Items 1 \& 2 from the Research Standards for Chronic Low-Back Pain (RScLBP) assessment).
• For females of reproductive potential: currently practicing an effective form of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, for at least 1 month prior to screening and agrees to use such a method during study participation and for an additional 4 weeks after the end of study medication administration unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year):
• oral contraceptives,
• contraceptive sponge,
• patch,
• double barrier (diaphragm/spermicidal or condom/spermicidal),
• intrauterine contraceptive system,
• etonogestrel implant,
• medroxyprogesterone acetate contraceptive injection,
• complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring.
• Agree (if male) to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of the first administration of the study drug until 30 days following the final administration of the study drug. One of the following acceptable methods of contraception must be utilized:

You may not qualify if:

• 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.
• Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities.
• Current use of Antiepileptic drugs.
• Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, muscle relaxants
• Current use of amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, or other tricyclic antidepressants within 3 months of randomization.
• Treatment with another investigational drug or other intervention within 3 months of the screening visit.
• Pregnancy, plans to become pregnant, or lactation.
• Any interventional pain procedures within 6 weeks prior to screening or at any point during study enrollment.
• Surgical intervention or introduction/increased dose of an opioid or analgesic regimen at any point during study enrollment.
• Implanted spinal cord or dorsal root ganglion stimulator for pain treatment.
• Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for a current major psychiatric illness, such as bipolar disorder, major depression, or psychosis.
• Have a history of substance abuse or dependence.
• Have a history or current suicidality. Have an increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and/or current suicidal plan, per investigator clinical judgement, based on interview and defined on the Columbia Suicidality Severity Rating Scale (C-SSRS).
• Have a history of seizures.

Sponsors & Collaborators

• Christopher D. Verrico: lead

Study Sites (1)

Michael E Debakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (7)

• Fitzcharles MA, Baerwald C, Ablin J, Hauser W. Efficacy, tolerability and safety of cannabinoids in chronic pain associated with rheumatic diseases (fibromyalgia syndrome, back pain, osteoarthritis, rheumatoid arthritis): A systematic review of randomized controlled trials. Schmerz. 2016 Feb;30(1):47-61. doi: 10.1007/s00482-015-0084-3.

  PMID: 26767993 BACKGROUND

• Johal H, Devji T, Chang Y, Simone J, Vannabouathong C, Bhandari M. Cannabinoids in Chronic Non-Cancer Pain: A Systematic Review and Meta-Analysis. Clin Med Insights Arthritis Musculoskelet Disord. 2020 Feb 19;13:1179544120906461. doi: 10.1177/1179544120906461. eCollection 2020.

  PMID: 32127750 BACKGROUND

• Kraft B, Frickey NA, Kaufmann RM, Reif M, Frey R, Gustorff B, Kress HG. Lack of analgesia by oral standardized cannabis extract on acute inflammatory pain and hyperalgesia in volunteers. Anesthesiology. 2008 Jul;109(1):101-10. doi: 10.1097/ALN.0b013e31817881e1.

  PMID: 18580179 BACKGROUND

• Madden A. Commentary on Madden et al. (2018): 'It's not only about the destination... it's also about the journey!' Consumer perspectives on a model of open-access MAT provision. Addiction. 2018 Aug;113(8):1459-1460. doi: 10.1111/add.14273. No abstract available.

  PMID: 29998623 BACKGROUND

• Cooper C, Spiers N, Livingston G, Jenkins R, Meltzer H, Brugha T, McManus S, Weich S, Bebbington P. Ethnic inequalities in the use of health services for common mental disorders in England. Soc Psychiatry Psychiatr Epidemiol. 2013 May;48(5):685-92. doi: 10.1007/s00127-012-0565-y. Epub 2012 Aug 15.

  PMID: 22893107 BACKGROUND

• Berthelot JM, Darrieutort-Lafitte C, Le Goff B, Maugars Y. Strong opioids for noncancer pain due to musculoskeletal diseases: Not more effective than acetaminophen or NSAIDs. Joint Bone Spine. 2015 Dec;82(6):397-401. doi: 10.1016/j.jbspin.2015.08.003. Epub 2015 Oct 6.

  PMID: 26453108 BACKGROUND

• de Vries JD, van Hooff MLM, Geurts SAE, Kompier MAJ. Exercise to reduce work-related fatigue among employees: a randomized controlled trial. Scand J Work Environ Health. 2017 Jul 1;43(4):337-349. doi: 10.5271/sjweh.3634. Epub 2017 Mar 21.

  PMID: 28323305 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Back Injuries

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Christopher D Verrico, phD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher D Verrico, PhD

CONTACT

713-791-1414; verrico@bcm.edu

Adetola O Vaughan, MA

CONTACT

713-791-1414; avaughan@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, Double-Blind, Placebo-Controlled, Parallel Groups

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: June 12, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-02

Locations

US (1)