The Effects of Sedatives on Tobacco Use Disorder Version 2

NCT05505630 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-29

No results posted yet for this study

Summary

Double-blind, placebo-controlled, randomized mechanistic clinical trial to test an intravenous dose of either ketamine, midazolam, dexmedetomidine, or a placebo (saline) on cigarette smoking behavior, craving, and neural effects.

Conditions

  • Tobacco Smoking

Interventions

DRUG

Ketamine

A single dose of IV ketamine will be administered.

DRUG

Midazolam

A single dose of IV midazolam will be administered

DRUG

Dexmedetomidine

A single dose of IV dexmedetomidine will be administered

DRUG

Saline

A single dose of IV saline will be administered

Sponsors & Collaborators

  • Nida Addiction Research Center

    collaborator UNKNOWN
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Merideth A Addicott, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-12-10
Completion
2025-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05505630 on ClinicalTrials.gov