RECRUITING

Effects of Dronabinol in Opioid Maintained Patients

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Twenty male and female (ages 18-70) participants with OUD currently receiving methadone or buprenorphine will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive dronabinol (2.5 mg, 5mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using a technique called the (QST) quantitative sensory testing, which involves the administering heat or cold stimulation. A Short-Form McGill Pain Questionnaire (SF-MPQ) and a pain Visual Analog Scale (VAS). Attentional bias will be measured using a visual probe task. Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery. The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum cytokine levels. One week after the last study medication dose, a follow-up session will be conducted during which participants will undergo urine toxicology testing and a safety evaluation before final discharge from the study.

Official Title

The Effects of Dronabinol in Opioid-Related Outcomes

Quick Facts

Study Start:2019-05-31

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04025359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Cannabis use, with recent cannabis exposure confirmed by urine toxicology. * Males and females, Veterans and non-Veterans, aged between 18 and 70. * Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment. * Capable of providing informed consent in English. * Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer. * Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months. * No current medical problems deemed contraindicated for participation by principal investigator. * For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.	* Currently meeting DSM-5 criteria for cannabis use disorder (CUD). * History of primary psychotic disorders or other current major psychiatric disorders deemed clinically unstable by the principal investigator. * Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator. * Inability to complete neuropsychological tests. * A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake inhibitors (SNRIs), (e.g. venlafaxine, duloxetine), tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, tegretol), benzodiazepines (e.g., alprazolam, diazepam), and other opioid drugs). Only subjects who are on stable doses of these medications, and whose dosing schedules allow participation in the study visits, will be enrolled. If possible, the morning dose will be administered after the study visit. * Liver function tests (ALT or AST) greater than 3x normal. * Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension. * Allergy or serious adverse reaction to cannabis, dronabinol or other cannabinoids.

Inclusion Criteria

Exclusion Criteria

* Cannabis use, with recent cannabis exposure confirmed by urine toxicology.
* Males and females, Veterans and non-Veterans, aged between 18 and 70.
* Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
* Capable of providing informed consent in English.
* Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
* Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
* No current medical problems deemed contraindicated for participation by principal investigator.
* For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.

* Currently meeting DSM-5 criteria for cannabis use disorder (CUD).
* History of primary psychotic disorders or other current major psychiatric disorders deemed clinically unstable by the principal investigator.
* Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
* Inability to complete neuropsychological tests.
* A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake inhibitors (SNRIs), (e.g. venlafaxine, duloxetine), tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, tegretol), benzodiazepines (e.g., alprazolam, diazepam), and other opioid drugs). Only subjects who are on stable doses of these medications, and whose dosing schedules allow participation in the study visits, will be enrolled. If possible, the morning dose will be administered after the study visit.
* Liver function tests (ALT or AST) greater than 3x normal.
* Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension.
* Allergy or serious adverse reaction to cannabis, dronabinol or other cannabinoids.

Contacts and Locations

Study Contact

Joao De Aquino, M.D.

CONTACT

203-932-5711

joao.deaquino@va.gov

Brendan Sullivan

CONTACT

203-932-5711

brendan.sullivan@va.gov

Principal Investigator

Joao De Aquino, M.D.

PRINCIPAL_INVESTIGATOR

VA healthcare System West Haven CT

Study Locations (Sites)

VA Healthcare System

West Haven, Connecticut, 06516

United States

Collaborators and Investigators

Sponsor: Yale University

Joao De Aquino, M.D., PRINCIPAL_INVESTIGATOR, VA healthcare System West Haven CT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-31

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2019-05-31

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Pain