Dronabinol as an Adjunct for Reducing Pain

Inclusion Criteria:

1. Provision of signed and dated informed consent form.

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

3. Ability to take oral medication per protocol.

4. Male or female, aged 18-64 years.

5. Has chronic low back pain (i.e., in the space between the lower posterior margin ofthe rib cage and the horizontal gluteal fold) that has persisted at least 3 monthsand has resulted in pain on at least half the days in the past 6 months (Items 1 & 2from the Research Standards for Chronic Low-Back Pain (RScLBP) assessment).

6. For females of reproductive potential: currently practicing an effective form of twotypes of birth control, which are defined as those, alone or in combination, thatresult in a low failure rate (i.e., less than 1% per year) when used consistentlyand correctly, for at least 1 month prior to screening and agrees to use such amethod during study participation and for an additional 4 weeks after the end ofstudy medication administration unless she is surgically sterile, partner issurgically sterile, or she is postmenopausal (one year):

7. oral contraceptives,

8. contraceptive sponge,

9. patch,

10. double barrier (diaphragm/spermicidal or condom/spermicidal),

11. intrauterine contraceptive system,

12. etonogestrel implant,

13. medroxyprogesterone acetate contraceptive injection,

14. complete abstinence from sexual intercourse, and/or hormonal vaginalcontraceptive ring.

15. Agree (if male) to use acceptable methods of contraception if the male participant'spartner could become pregnant from the time of the first administration of the studydrug until 30 days following the final administration of the study drug. One of thefollowing acceptable methods of contraception must be utilized:

16. Surgical sterilization (vasectomy)

17. The participant's female partner uses oral contraceptives (combinationestrogen/progesterone pills), injectable progesterone or sub dermal implants (commenced at least 14 days prior to study drug administration to the maleparticipant)

18. The participant's female partner uses a medically prescribed topically appliedtransdermal contraceptive patch (commenced at least 14 days prior to study drugadministration to the male participant)

19. The participant's female partner has undergone tubal ligation (femalesterilization) or is postmenopausal (one year)

20. The participant's female partner has undergone placement of an intrauterinedevice or intrauterine system.

21. True abstinence: when this is in line with the preferred and usual lifestyle ofthe participant.

22. Agreement to adhere to Lifestyle Considerations throughout study duration.

23. On a stable pain treatment (pharmacological or otherwise) for ≥3 months at the timeof the screening.

Exclusion Criteria:

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

2. Known allergic reactions to cannabis, CBD, THC, or components of the studyinterventions.

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

4. Current use of Antiepileptic drugs.

5. Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, musclerelaxants

6. 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.

7. Treatment with another investigational drug or other intervention within 3 months ofthe screening visit.

8. Pregnancy, plans to become pregnant, or lactation.

9. Any interventional pain procedures within 6 weeks prior to screening or at any pointduring study enrollment.

10. Surgical intervention or introduction/increased dose of an opioid or analgesicregimen at any point during study enrollment.

11. Implanted spinal cord or dorsal root ganglion stimulator for pain treatment.

12. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria fora current major psychiatric illness, such as bipolar disorder, major depression, orpsychosis.

13. Have a history of substance abuse or dependence.

14. Have a history or current suicidality. Have an increased risk of suicide thatnecessitates inpatient treatment or warrants therapy excluded by the protocol,and/or current suicidal plan, per investigator clinical judgement, based oninterview and defined on the Columbia Suicidality Severity Rating Scale (C-SSRS).

15. Have a history of seizures.

16. Have uncontrolled renal, hepatic, or other systemic disorders that in the opinion ofthe investigator may jeopardize the patient.

17. Have a history of cardiac disorders.

18. Myocardial infarction or stroke in the previous 6 months.

19. Resting heart rate of > 120.

20. Systolic blood pressure > 140 mm Hg, or diastolic blood pressure > 90 mm Hg.

21. Any uncontrolled communicable disease (e.g., human immunodeficiency virus (HIV),acquired immunodeficiency syndrome (AIDS), tuberculosis, coronavirus disease (COVID), etc.).

22. Have any other illness, condition, or use of medications, which in the opinion ofthe P.I. and/or the admitting clinician would preclude the safe and/or successfulcompletion of the study.

23. Have a history of head trauma, epilepsy, or a cognitive disorder (Alzheimer'sDisease, dementia).

24. Have an electrocardiogram (ECG) abnormalities at screening including but not limitedto bradycardia (<55 beats per minute); prolonged heart-rate corrected QT interval (QTc) interval (>450 msec); Wolff-Parkinson White syndrome; wide complextachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left orright bundle branch block; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).