NCT02407808

Brief Summary

The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Feb 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress88%
Feb 2015Dec 2027

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

April 29, 2026

Status Verified

June 1, 2025

Enrollment Period

3.5 years

First QC Date

March 31, 2015

Last Update Submit

April 23, 2026

Conditions

CannabisPsychotic Disorders

Outcome Measures

Primary Outcomes (2)

  • Rey Auditory Verbal Learning Test (RAVLT)

    a measure of verbal episodic memory

    +35 minutes after infusion

  • N-Back Task

    a measure of working memory

    +65 minutes after infusion

Secondary Outcomes (2)

  • Clinician Administered Dissociative Symptoms Scale (Total Score)

    Baseline, +10, +85, and +240 minutes after the first infusion

  • Visual Analog Scale (Total Score)

    Baseline, +10, +85, +240 minutes after the first infusion

Study Arms (2)

THC

ACTIVE COMPARATOR

Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.

Drug: THCDrug: Placebo

Placebo

PLACEBO COMPARATOR

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

Drug: THCDrug: Placebo

Interventions

THCDRUG

Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.

PlaceboTHC
PlaceboDRUG

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

PlaceboTHC

Eligibility Criteria

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

You may qualify if:

  • Men and women aged 18 and 55 years (extremes included) on day of first dosing
  • Exposed to cannabis at least once in their lifetime

You may not qualify if:

  • Cannabis naive
  • Positive pregnancy screen during screening
  • Hearing deficits

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

Dronabinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Mohini Ranganathan, M.D.

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
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

March 31, 2015

First Posted

April 3, 2015

Study Start

February 1, 2015

Primary Completion

August 10, 2018

Study Completion (Estimated)

December 1, 2027

Last Updated

April 29, 2026

Record last verified: 2025-06

Locations

US(1)