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Glucocorticoid Antagonist Treatment for Tobacco Use Disorder

NCT03248713 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-05-28

No results posted yet for this study

Summary

The purpose of this protocol is to examine whether mifepristone, a medication with glucocorticoid receptor antagonist activity, may be a potential treatment for Tobacco Use Disorder (TUD). Mifepristone has already shown promise as a potential treatment for PTSD (1) and alcohol use disorder (AUD) (2), but no previous studies have examined the therapeutic potential of mifepristone for TUD. This will be a double-blind, placebo-controlled study on the effects of a 7-day treatment with 600 mg mifepristone, or placebo, on cognitive function, tobacco withdrawal severity, and smoking behavior.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Mifepristone

Mifepristone 600mg 2 tablets will be compared to the placebo

DRUG

Placebo

Placebo sugar 2 tablets will be compared to mifepristone

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Mehmet Sofuoglu, M.D.,Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2019-05-20
Completion
2019-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03248713 on ClinicalTrials.gov