NCT00946348

Brief Summary

The first aim of this study is to determine whether a brain reward center (BRC) deficiency in patients with schizophrenia (SCZ) and cannabis use disorder (CUD) will be normalized when patients are given cannabis or dronabinol. The second aim will serve to further assess the effects of dronabinol on symptoms and medication side effects in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_1 schizophrenia

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

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 29, 2014

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

July 24, 2009

Results QC Date

April 9, 2014

Last Update Submit

July 8, 2021

Conditions

SchizophreniaDual DiagnosisSchizoaffective DisorderPsychotic DisorderCannabis Use Disorder

Keywords

DronabinolSchizophreniaDual DiagnosisSubstance AbuseCannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

  • fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).

    Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.

    Measures were acquired at peak THC level for each of the two drugs up to 4 hours.

Secondary Outcomes (1)

  • To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.

    Over 8 hours

Study Arms (2)

Dronabinol

EXPERIMENTAL

Dronabinol 10mg or 15 mg

Drug: Dronabinol

Cannabis

ACTIVE COMPARATOR

Cannabis cigarette

Drug: Cannabis

Interventions

DronabinolDRUG

Dronabinol 10 mg or 15 mg

Also known as: Marinol
Dronabinol
CannabisDRUG

Cannabis cigarette

Also known as: Marijuana
Cannabis

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50;
  • Diagnosis of schizophrenia or schizoaffective disorder (by SCID)
  • Diagnosis of current cannabis abuse or dependence (by SCID);
  • Recent use of cannabis (within the past month on Timeline Follow-Back);
  • Stability on antipsychotic medication for past 1 month);
  • Outpatient status for past 3 months;
  • Willing and able to participate as demonstrated by a signed informed consent document.
  • Age 18-50;
  • Willing to participate as demonstrated by a signed informed consent document

You may not qualify if:

  • PANSS subscale for positive symptoms of psychosis item \> 3 \[moderate\] on Day 15 (once they are abstinent from cannabis);
  • Cocaine/stimulant use disorder;
  • Pharmacological treatment for addiction (e.g., disulfiram, naltrexone, acamprosate, topiramate); Mental retardation;
  • Pregnancy or currently nursing;
  • Uncontrolled serious medical condition;
  • Seizure disorder
  • Seeking treatment to limit their cannabis use
  • Taking clozapine
  • Claustrophobia prohibiting scanning
  • History of head injury with period of unconsciousness;
  • Metal objects within the body;
  • Taking antipsychotic other than risperidone or first generation antipsychotic as main treatment
  • Previous participation in the Pilot Dose Finding Study
  • Axis I or Axis II psychiatric diagnosis (including substance use disorder) based on SCID
  • Mental retardation;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSubstance-Related Disorders

Interventions

Dronabinolnabiximols

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Alan I. Green, M.D.
Organization
Geisel School of Medicine at Dartmouth
alan.i.green@dartmouth.edu
603-650-7549

Study Officials

  • Alan I Green, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

July 12, 2021

Results First Posted

September 29, 2014

Record last verified: 2021-07

Locations

US(1)