Study to Test the Safety and Efficacy of Cannabidiol as a Treatment Intervention for Opioid Relapse

NCT01311778 | Completed Phase 1 DMC

• 1 other identifier: R21DA027781
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the current available therapies for opioid-dependent patients, most patients relapse. This research project focuses on the development of a novel compound, cannabidiol, to modulate opioid craving in humans based on animal models showing its selective effectiveness to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse would be of tremendous medical and public health value.

Conditions

Opiate Addiction

Outcome Measures

Primary Outcomes (1)

• To determine the safety of cannabidiol oral administration prior to fentanyl IV administration.

  We will assess safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Excessive sedation (GCS\<10), cardiac dysrhythmia (on telematry monitor), hypotension (blood pressure \< 90/60 mmHg), bradycardia (heart rate 50/minute),severe anxiety, or seizures (partial or generalized tonic-clonic) after the administration of either Fentanyl or Cannabidiol would result in discontinuation of the study for the subject and immediate medical attention.

  9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480

Secondary Outcomes (13)

• General cannabidiol pharmacokinetics

  9 timepoints: -10 min, 30, 60, 90, 120, 180, 240, 360, 480

• Cortisol levels

  -10 min, 30, 60, 90, 120, 180, 240, 360, 480

• Cannabidiol clearance

  5 timepoints: -60 min, 45, 120, 240, 480

• Vital signs-BP

  -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min

• Vital signs-HR

  -10, 30, 60, 75, 90, 120, 180, 240, 360, 480 min

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo

Drug: Fentanyl

CBD 400 mg

EXPERIMENTAL

Subjects will receive 400 mg CBD

Drug: Cannabidiol; Drug: Fentanyl

CBD 800mg

EXPERIMENTAL

Subjects will receive 800 mg CBD

Drug: Cannabidiol; Drug: Fentanyl

Interventions

Cannabidiol DRUG

Subjects in Arm CBD 400 mg will receive 400 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl. Subjects in Arm CBD 800 mg will receive 800 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl.

CBD 400 mg; CBD 800mg

Fentanyl DRUG

All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)

Also known as: Fentanyl Citrate

CBD 400 mg; CBD 800mg; Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being aged between 21 and 65 years old.
• having exposure at least once to an opioid (i.e. codeine, morphine, Fentanyl) in the past

You may not qualify if:

• using any psychoactive drug or medication at any time during the study, or 24 hours before the test session
• having a past or current diagnosis of drug abuse or dependence (except for nicotine), based on the SCID-IV interview (Structured Clinical Interview for DSM-IV)
• being maintained on methadone or buprenorphine, or taking opioid antagonist such as naltrexone
• having taken any opioid in the last 14 days
• having medical conditions, including Axis I psychiatric conditions under DSM-IV (examined with the MINI International Neuropsychiatric Interview-MINI), history of cardiac disease, arrhythmias, head trauma, and seizures
• having a history of hypersensitivity to any opioid or cannabinoid
• being pregnant or breastfeeding
• not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. spermicide, diaphragm)
• arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen for cocaine, cannabis, opiates, benzodiazepines, barbiturates, phencyclidine and amphetamines
• being actively treated and currently involved in an addiction treatment program
• being an anesthesiologist or a pharmacist

Sponsors & Collaborators

• Hurd,Yasmin, Ph.D.: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cannabidiol; Fentanyl

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yasmin Hurd, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 10, 2011
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

US (1)