Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?

NCT01964404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2025-12-09

Study results available
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Summary

In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.

Conditions

  • Schizophrenia
  • Dual Diagnosis
  • Psychotic Disorder
  • Cannabis Use Disorder

Interventions

DRUG

Marijuana

Smoked plant with THC

DRUG

Dronabinol

Capsule with THC

DRUG

Placebo

Capsule with no active ingredient

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER
  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • Massachusetts Institute of Technology

    collaborator OTHER
  • Massachusetts General Hospital

    collaborator OTHER
  • Nathan Kline Institute for Psychiatric Research

    collaborator OTHER
  • University of Vermont

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Mary F Brunette, MD · Dartmouth College

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2021-09-18
Completion
2021-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964404 on ClinicalTrials.gov