Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans

NCT02539823 | Completed Phase 2 Results DMC

• 1 other identifier: MSBI HSM# 087-14
• Study Type: interventional
• Target: 45
• 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 (2)

• Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue (30 Minutes), and From Test Day 1 Through Test Day 4 (1 Week)) - Via the Visual Analog Scale for Craving (VASC)

  The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions in the clinic will be measured. Note, cue sessions occur consecutively in the same test day. In this way, changes in craving from baseline (pre-cue to post-cue within each test day), as well as changes in cue-induced craving over the short-term (test day 1 through test day 4 a week later) will be monitored and measured. VASC scale ranges from 0 for "Not Craving at All" to 10 for "Extremely Craving."

  VASC: test day I, II and IV - at arrival, baseline for cue 1 and 2, post-cue 1 and 2, before discharge (approximately 2.5 hours from session start on average); test day III: at arrival and discharge (approx. 2.5 hours from session start on average)

• Changes in Out-of-Clinic Craving (From Pre-dose to Approximately 4-6 Hours Post-dose; and From Test Day 1 to Test Day 4 or 1 Week) - Via the Heroin Craving Questionnaire (HCQ)

  Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test day 1 through test day 4 (1 week later). Each item is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree." Sum of all 14 items are scored and added. Mean scores reported below. Total Score Range: 14 (less cravings) - 98 (more cravings).

  HCQ: once in clinic pre-dose at each test day, and once at home after each test day.

Secondary Outcomes (1)

• Vital Signs

  Pre-placebo/drug, -60 min pre-cue, -40 min pre-cue, -20 min pre-cue, cue (time 0), 15 min post-cue, 35 min post-cue, 50 min post-cue, 65 min post-cue, 85 min post-cue

Other Outcomes (6)

• CBD Effects on Cognitive Behavior

  2 times: once at pre-screening and once at test day 4, within 2 weeks of each other.

• Visual Analog Scale for Anxiety (VASA)

  Test day I, II and IV: on arrival, baseline for cue sessions 1 and 2, post-cue sessions I and 2 (30 min from baseline), prior to discharge (approximately 2.5 hours from test day start on average); Test day III: on arrival and prior to discharge.

• The Positive and Negative Affect Schedule(PANAS)

  Baseline for cue sessions 1 and 2, post-cue sessions I and 2 (30 min from baseline) during test days I, II and IV.

Study Arms (3)

Control

PLACEBO COMPARATOR

Subjects will receive a solution that resemble the Cannabidiol solution but do not have have its properties

Drug: Control (placebo)

CBD 400mg

EXPERIMENTAL

Subjects will receive 400mg of cannabidiol

Drug: CBD 400 mg

CBD 800mg

EXPERIMENTAL

Subjects will receive 800 mg of cannabidiol

Drug: CBD 800 mg

Interventions

CBD 400 mg DRUG

Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions

Also known as: CBD

CBD 400mg

CBD 800 mg DRUG

Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Also known as: CBD

CBD 800mg

Control (placebo) DRUG

Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Also known as: CBD

Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between 21 and 65 years old
• Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months
• No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

You may not qualify if:

• Using any psychoactive drug (other than nicotine) any time up to test session 3
• Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-V interview criteria
• Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
• Having a positive a drug screen
• Showing signs of acute heroin withdrawal symptoms
• Having medical conditions, including Axis I psychiatric conditions under DSM-V (examined using the Mini International Neuropsychiatric Interview \[MINI\])
• Having a a history of cardiac disease, arrhythmias, head trauma, and seizures
• Having a history of hypersensitivity to cannabinoids
• 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
• Participating in a another pharmacotherapeutic trial in the past 3 months
• Being pregnant of breastfeeding
• Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)

Sponsors & Collaborators

• Hurd,Yasmin, Ph.D.: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Related Publications (1)

• Hurd YL, Spriggs S, Alishayev J, Winkel G, Gurgov K, Kudrich C, Oprescu AM, Salsitz E. Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):911-922. doi: 10.1176/appi.ajp.2019.18101191. Epub 2019 May 21.

  PMID: 31109198 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Yasmin Hurd, PhD
• Organization: Icahn School of Medicine at Mount Sinai

yasmin.hurd@mssm.edu

212 824 9314

Study Officials

• Yasmin Hurd, PhD

  Mount Sinai Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Professor of Neuroscience, Psychiatry and Pharmacology & Systems Therapeutics

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 3, 2015
• Study Start: September 1, 2015
• Primary Completion: May 24, 2017
• Study Completion: May 24, 2017
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2022-08

Locations

US (1)