Is NCT05269628 recruiting in Ann Arbor, MI?

Yes, NCT05269628 is currently recruiting participants at its Ann Arbor, MI location. This multiple sclerosis clinical trial is actively enrolling qualified participants.

How do I join the multiple sclerosis clinical trial in Ann Arbor?

To join this clinical trial in Ann Arbor, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Ann Arbor clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Multiple Sclerosis Clinical Trial in Ann Arbor, MI

About This Multiple Sclerosis Study in Ann Arbor

The purpose of this research study is to compare the effects of cannabidiol (CBD), tetrahydrocannabinol (THC), or both, on sleep and pain in persons with multiple sclerosis (MS). Little is known about how CBD and/or THC may help sleep, reduce pain, or perhaps even treat pain through better sleep.

Sponsor: Tiffany J. Braley, MD, MS

Who Can Participate

Inclusion Criteria

Patients with clinically definite MS (those who are on a disease modifying therapy must be on a stable dose without evidence of liver toxicity for at least 3 months);

Presence of chronic pain defined as moderate to severe pain for at least 3 months, based on a 0-10 numeric rating scale (NRS);

Willingness to maintain stable analgesic regimen during study period;

Recent serum aspartate transaminase, alanine transaminase, and bilirubin testing within 90 days of screening;

Exclusion Criteria

Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test;

History of MS relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window);

Pain due to cancer;

Pregnancy or breastfeeding;

Current cannabinoid use (participants may be reconsidered for inclusion after 30-day washout) and/or unwillingness to abstain from cannabinoids in any form from 30 days prior to the study of the study drugs and until the last follow up phone call at the end of the study (30 - 37 days after taking the last dose of the study drug).

Unwillingness to use contraception from screening until the end of drug treatment

Current suicidal ideation (SI) with intent and/or plan; these individuals will be assessed by a study psychologist and referred for urgent mental health treatment as indicated;

Current severe depression as indicated by a PHQ-9 score of ≥ 17 that includes indicators of significant depressed mood (sum of items #1 and #2 ≥ 5).

History of mania or schizophrenia diagnosis

Known hypersensitivity to cannabinoids in general, or Epidiolex® or Dronabinol specifically or its excipients (e.g., sesame oil)

History of the following cardiovascular conditions: recent myocardial infarction or stroke (last 6 months prior to screening), unstable angina, left ventricular hypertrophy, mitral valve prolapses, severe coronary artery disease, NYHA class III or IV congestive heart failure.

History severe hepatic impairment (must have blood AST ≤ 2.0x ULN, ALT ≤ 2,0x ULN, and bilirubin ≤ 1.5x ULN within the last 90 days (AST, ALT, bilirubin testing will be required within 90 days of screening);

History of seizure disorder (recurrent, unprovoked seizures not explained by a known reversible cause) or history of certain types of head injury that could cause an increased risk of seizures;

History of prescription or illicit drug abuse (such as cocaine, amphetamine, methamphetamine, heroin);

Current risk for alcohol misuse as indicated by a score of ≥ 8 on the Alcohol Use Disorders Identification Test (AUDIT) self-report measure.

Current warfarin, valproate or clobazam use.

Current use of known moderate or strong inhibitors of CYP3A4 \[topical ketoconazole, and temporary (\<= 4 week) oral courses of clarithromycin, fluconazole and itraconazole will be allowed\].

Current use of strong inducers of CYP3A4 or CYP2C19 (does not include glucocorticoids or modafinil/armodafinil, which are permitted),

Current use of moderate or strong inhibitors/inducers of CYP2C9, and narrow therapeutic index drugs (e.g., cyclosporine, amphotericin B).

Current use of known non-minor Sensitive CYP2C19 Substrates, with the exception of some proton pump inhibitors (e.g., esoprazole, omeprazole)), periodic self-limited courses of diazepam (e.g., for MRI sedation) and submaximal doses of some antidepressant class medications (e.g., citalopram, and escitalopram), which will be permitted by the discretion of the treating neurologist PI.

Refusal to avoid grapefruit or grapefruit products during the study treatment interval.

Current use of opioids (tramadol permitted).

Employed as a commercial driver or employed in an occupation that involves extreme heights or use of heavy machinery.

History of car crashes or near-crashes due to untreated sleepiness that has led to near-misses in the past 6 months.

Cognitive dysfunction as indicated by \>=3 errors on the six-item cognitive screener

Expanded Disability Status Scale (EDSS) score \>=8.0.

Blood pressure at screening above 180 mmHg systolic and/or 120 mmHg diastolic, or below 90 mmHg systolic and or 60 mmHg diastolic, or history of syncope related to orthostatic hypotension;

Resting heart rate at screening less than 50 bpm or greater than 100 bpm;

Any other treatment or medical, neurological, sleep, or psychiatric condition that, in the opinion of the investigators, could affect participant safety or eligibility.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT05269628) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Sclerosis Treatment Options in Ann Arbor, MI

If you're searching for multiple sclerosis treatment options in Ann Arbor, MI, this clinical trial (NCT05269628) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced multiple sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple sclerosis clinical trials near you to find additional studies recruiting in your area.

Multiple Sclerosis Clinical Trial in Ann Arbor, MI

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