NCT01591629

Brief Summary

The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

April 25, 2012

Last Update Submit

February 23, 2022

Conditions

Healthy

Keywords

CannabisMarijuanaNaloxoneTHCPsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • Behavioral Measures

    Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).

    4 test days

Secondary Outcomes (7)

  • Visual analog scales

    4 test days

  • Clinician Administered Dissociative States Scales (CADSS)

    4 test days

  • Psychotomimetic States Inventory (PSI)

    4 test days

  • Marijuana Withdrawal Scale

    4 test days

  • Clinical Opiate Withdrawal Scale

    4 test days

  • +2 more secondary outcomes

Study Arms (4)

Placebo and Placebo

PLACEBO COMPARATOR
Drug: Placebo

Active Naloxone and Placebo

EXPERIMENTAL
Drug: NaloxoneDrug: Placebo

Placebo and Active Delta-9-THC

PLACEBO COMPARATOR
Drug: Delta-9-THCDrug: Placebo

Active Naloxone and Active Delta-9-THC

EXPERIMENTAL
Drug: NaloxoneDrug: Delta-9-THC

Interventions

NaloxoneDRUG

Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push

Active Naloxone and Active Delta-9-THCActive Naloxone and Placebo
Delta-9-THCDRUG

Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Active Naloxone and Active Delta-9-THCPlacebo and Active Delta-9-THC
PlaceboDRUG

Placebo

Active Naloxone and PlaceboPlacebo and Active Delta-9-THCPlacebo and Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least one exposure to Cannabis

You may not qualify if:

  • Cannabis Naive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Marijuana AbusePsychotic Disorders

Interventions

NaloxoneDronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 25, 2012

First Posted

May 4, 2012

Study Start

November 4, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

US(1)