NCT02335060

Brief Summary

The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started May 2014

Shorter than P25 for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

May 2, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

January 5, 2015

Last Update Submit

January 19, 2022

Conditions

Healthy

Keywords

cannabisMarijuanaTHCN-acetylcysteinePsychotic Disorders

Outcome Measures

Primary Outcomes (5)

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS)

    Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS

    -30 minutes from administration of THC

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS)

    Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS

    +15 minutes from administration of THC

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS)

    Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS

    +90 minutes from administration of THC

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS)

    Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS

    +240 minutes from administration of THC

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS)

    Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS

    -60 minutes from administration of THC

Secondary Outcomes (5)

  • Clinician Administered Dissociative Symptoms Scale (CADSS)

    -60min, -30min, +15min, +90min, +240min from administration of THC

  • Visual Analog Scale (VAS)

    -60min, -30min, +15min, +90min, +240min from administration of THC

  • Cognitive Test Battery

    +20min from administration of THC

  • Hopkins Verbal Learning Test (HVLT)

    +20min from administration of THC

  • Psychotomimetic States Inventory (PSI)

    -60min, -30min, +240min from administration of THC

Study Arms (4)

Active N-acetylcysteine and Active Delta-9-THC

EXPERIMENTAL
Drug: Delta-9-THCDrug: N-acetylcysteine

Placebo and Active Delta-9-THC

PLACEBO COMPARATOR
Drug: Delta-9-THCDrug: Placebo

Active N-acetylcysteine and Placebo

EXPERIMENTAL
Drug: N-acetylcysteineDrug: Placebo

Placebo and Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Delta-9-THCDRUG

Active Delta-9-THC (0.036mg/Kg) given intravenously.

Active N-acetylcysteine and Active Delta-9-THCPlacebo and Active Delta-9-THC
N-acetylcysteineDRUG

A pill given orally.

Active N-acetylcysteine and Active Delta-9-THCActive N-acetylcysteine and Placebo
PlaceboDRUG

Placebo (about a quarter spoon of alcohol with no THC) given intravenously.

Active N-acetylcysteine and PlaceboPlacebo and Placebo

Eligibility Criteria

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

You may qualify if:

  • Exposed to Cannabis at least once in lifetime

You may not qualify if:

  • Cannabis Naive
  • Individuals with a documented allergy to N-acetylcysteine

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

DronabinolAcetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic ChemicalsCysteineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Mohini Ranganathan, MD

    Yale University Medical School

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 9, 2015

Study Start

May 2, 2014

Primary Completion

September 16, 2014

Study Completion

September 16, 2014

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

US(1)