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Effects of Dronabinol in Opioid Maintained Patients (THC)

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ClinicalTrials.gov Identifier: NCT04025359
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Mehmet Sofuoglu, VA Office of Research and Development

Brief Summary:
Twenty male and female (ages 18-60) 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 (10, 20mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using the well-validated Cold Pressor Test (CPT), the 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Dronabinol Drug: Placebos Early Phase 1

Detailed Description:
This is a double-blind, randomized, placebo-controlled cross-over human laboratory study. Participants will be asked to come to the testing site for a total of four times: one initial screening session (~ 3 hours) and three test days (~ 6 hours each) where study medication will be administered, separated by at least 72 hours to limit carryover effects for dronabinol administration. Twenty male and female participants with OUD on MAT will be asked to arrive at approximately the same time each morning, coordinating with attendance at their opioid maintenance clinic. Subjects will be asked to refrain from using alcoholic beverages and drugs during study participation. Urine screens and breathlyzer measurements will be done before the test sessions to check abstinence from drugs (e.g., cocaine, illicit opioids, benzodiazepines, barbiturates, and amphetamines) and alcohol respectively. Those who are non-compliant will be discharged from the study. To minimize nicotine and withdrawal effects on cognitive performance, subjects who smoke will be advised to continue smoking as usual. Since we will provide a standard breakfast, participants will be asked not to eat for two hour before they arrive for the test sessions. A study nurse will confirm with their respective program that participants did not receive either methadone or buprenorphine that morning, and will call the program when testing is complete to permit dispersal of that day's methadone or buprenorphine dose. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum cytokine levels. Participants will undergo a variety of cognitive and self-report measures, as well as assessments to confirm restraint from illicit drug use and lack of adverse effects of medication. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive dronabinol (10 mg, 20 mg) or placebo. Subsequently, all participants will undergo laboratory testing of measures relevant to vulnerability to relapse, including physiological, subjective and cognitive outcomes. The order of study medication administration will be counterbalanced order to minimize the impact of potential carryover effects between the sessions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind, randomized, placebo-controlled cross-over human laboratory study. Participants will be asked to come to the testing site for a total of four times: one initial screening session (~ 3 hours) and three test days (~ 6 hours each) where study medication will be administered, separated by at least 72 hours to limit carryover effects for dronabinol administration.
Masking: Double (Participant, Investigator)
Masking Description: Medication will be prepared by pharmacy into blue capsules as to mask the actual dosage
Primary Purpose: Health Services Research
Official Title: The Effects of Dronabinol in Opioid-Related Outcomes
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Active Comparator: Dronabinol 10mg
Dronabinol 10mg
Drug: Dronabinol
Dronabinol 10Mg
Other Name: Marinol

Active Comparator: Dronabinol 20mg
Dronabinol 20mg
Drug: Dronabinol
dronabinol 20Mg
Other Name: Marinol

Placebo Comparator: Placebo
Placebo
Drug: Placebos
sugar pill
Other Name: sugar pill




Primary Outcome Measures :
  1. Pain and threshold measured by the Cold Pressor Test (CPT). [ Time Frame: up to 3 weeks ]
    Pain from cold pressor test will reduce



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025359


Contacts
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Contact: Joao De Aquino, M.D. 203-932-5711 ext 2916 joao.deaquino@va.gov
Contact: Brendan Sullivan 203-932-5711 ext 3350 brendan.sullivan@va.gov

Locations
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United States, Connecticut
VA Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Joao De Aquino, M.D.    203-932-5711 ext 2916    joao.deaquino@va.gov   
Contact: Brendan Sullivan    203-932-5711 ext 33500    brendan.sullivan@va.gov   
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D.         
Sponsors and Collaborators
Yale University
US Department of Veterans Affairs
Investigators
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Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. VA healthcare System West Haven CT

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Responsible Party: Mehmet Sofuoglu, Principal Investigator, VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04025359     History of Changes
Other Study ID Numbers: MS056
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists