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Dronabinol for Pain Management in Opioid Users (THC Trial)

Q: Are individuals over thirty accepted into the experiment?

This study necessitates that participants are between 18 and 70 years of age. Conversely, for minors or elderly patients there are 71 trials specifically designed for those below the age of 18 and 269 clinical studies dedicated to individuals over 65 respectively.

Q: Is it still feasible to join this clinical trial at present?

Affirmative, the clinicaltrials.gov repository implies that this experiment is presently in search of participants. This trial was first advertised on May 31st 2019 and its information was most recently amended on October 21st 2022. It seeks 36 individuals from a single site.

Q: What are the predominant medical conditions targeted by Dronabinol 20mg?

The therapeutic use of dronabinol at a dosage of 20mg can be deployed to combat <a href="https://www.withpower.com/clinical-trials/weight-loss">weight loss</a>, while also being able to address unresponsiveness to standard treatments, drug therapy and anorexia.

Q: Could you provide further details of the research performed utilizing Dronabinol 20mg?

Presently, 38 clinical trials are exploring the effects of Dronabinol 20mg with 6 at Phase 3. Belmont, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> is hosting several of these studies while a total 90 sites worldwide have opened their doors to trialists.

Q: What is the intake capacity of this trial?

Affirmative. The information on clinicaltrials.gov reveals that this medical study is actively seeking participants and was first posted in May of 2019, with the latest edit taking place in October 2022. 36 people are expected to join from a single location.

Q: Who meets the criteria to participate in this research trial?

This clinical trial seeks 36 patients of ages between 18 and 70 that suffer from <a href="https://www.withpower.com/clinical-trials/pain">pain</a>. To be considered, they must not have any substance use disorders other than opioid use disorder or tobacco in the last 12 months, their <a href="https://www.withpower.com/clinical-trials/cannabis">cannabis</a> usage needs to be confirmed through a urine toxicology test, veterans and non-veterans are equally welcome for this study, an English informed consent is required as well as compliance with maintenance treatment such as methadone or buprenorphine; no current medical problems should impede participation and if female then <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a> testing along with <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> methods need to be taken into account.

Phase < 1

Recruiting

Led By Mehmet Sofuoglu, M.D., Ph.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment

Capable of providing informed consent in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 hours

Awards & highlights

THC Trial Summary

This trial will test the effects of dronabinol, a medication derived from marijuana, on people with opioid addiction who are receiving methadone or buprenorphine. The study will measure pain sensitivity, attentional bias, negative affect, and cognitive performance.

Who is the study for?

This trial is for men and women aged 18-70 with opioid use disorder (OUD) who are on stable methadone or buprenorphine treatment. Participants must not be pregnant, should use birth control, have recent cannabis exposure without a cannabis use disorder, and no major medical issues or other substance use disorders.Check my eligibility

What is being tested?

The study tests the effects of Dronabinol versus placebo in patients maintained on opioids. It involves taking the study medication before their regular dose of methadone or buprenorphine and then undergoing pain sensitivity tests, attentional bias tasks, mood assessments, cognitive performance evaluations, and blood tests to measure cytokines.See study design

What are the potential side effects?

Dronabinol may cause side effects such as changes in mood or perception since it's related to substances found in cannabis. Other possible side effects include dizziness, stomach discomforts like nausea or vomiting, weakness or lack of energy.

THC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently receiving methadone or buprenorphine for opioid use disorder.

Select...

I can understand and sign the consent form in English.

THC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain sensitivity, measured by the Cold Pressor Test (CPT).

Pain sensitivity, measured by the Short form of the McGill Pain Questionnaire (SF-MPQ).

Secondary outcome measures

Abuse potential, measured by the Drug Effects Questionnaire (DEQ).

Cognitive Performance, measured by the Continuous Performance Test (CPT)

Cognitive Performance, measured by the Hopkins Verbal Learning Test (HVLT).

THC Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Dronabinol 5mgActive Control1 Intervention

Dronabinol 5mg

Group II: Dronabinol 2.5mgActive Control1 Intervention

Dronabinol 2.5mg

Group III: PlaceboPlacebo Group1 Intervention

Placebo

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED

868 Previous Clinical Trials

487,854 Total Patients Enrolled

13 Trials studying Pain

2,931 Patients Enrolled for Pain

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,177 Total Patients Enrolled

14 Trials studying Pain

3,294 Patients Enrolled for Pain

Mehmet Sofuoglu, M.D., Ph.D.Principal InvestigatorVA healthcare System West Haven CT

12 Previous Clinical Trials

444 Total Patients Enrolled

2 Trials studying Pain

54 Patients Enrolled for Pain

Media Library

Dronabinol 5mg Clinical Trial Eligibility Overview. Trial Name: NCT04025359 — Phase < 1

Pain Research Study Groups: Dronabinol 5mg, Dronabinol 2.5mg, Placebo

Pain Clinical Trial 2023: Dronabinol 5mg Highlights & Side Effects. Trial Name: NCT04025359 — Phase < 1

Dronabinol 5mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT04025359 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over thirty accepted into the experiment?

"This study necessitates that participants are between 18 and 70 years of age. Conversely, for minors or elderly patients there are 71 trials specifically designed for those below the age of 18 and 269 clinical studies dedicated to individuals over 65 respectively."

Answered by AI

Is it still feasible to join this clinical trial at present?

"Affirmative, the clinicaltrials.gov repository implies that this experiment is presently in search of participants. This trial was first advertised on May 31st 2019 and its information was most recently amended on October 21st 2022. It seeks 36 individuals from a single site."

Answered by AI

What are the predominant medical conditions targeted by Dronabinol 20mg?

"The therapeutic use of dronabinol at a dosage of 20mg can be deployed to combat weight loss, while also being able to address unresponsiveness to standard treatments, drug therapy and anorexia."

Answered by AI

Could you provide further details of the research performed utilizing Dronabinol 20mg?

"Presently, 38 clinical trials are exploring the effects of Dronabinol 20mg with 6 at Phase 3. Belmont, Massachusetts is hosting several of these studies while a total 90 sites worldwide have opened their doors to trialists."

Answered by AI

What is the intake capacity of this trial?

"Affirmative. The information on clinicaltrials.gov reveals that this medical study is actively seeking participants and was first posted in May of 2019, with the latest edit taking place in October 2022. 36 people are expected to join from a single location."

Answered by AI

Who meets the criteria to participate in this research trial?

"This clinical trial seeks 36 patients of ages between 18 and 70 that suffer from pain. To be considered, they must not have any substance use disorders other than opioid use disorder or tobacco in the last 12 months, their cannabis usage needs to be confirmed through a urine toxicology test, veterans and non-veterans are equally welcome for this study, an English informed consent is required as well as compliance with maintenance treatment such as methadone or buprenorphine; no current medical problems should impede participation and if female then pregnancy testing along with birth control methods need to be taken into account."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Dronabinol in Opioid Maintained Patients

2019. "Effects of Dronabinol in Opioid Maintained Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04025359.

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