The Effects of Sedatives on Tobacco Use Disorder Version 2

Description

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

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Study Overview

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Study Details

Study overview

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.

The Effects of Sedatives on Tobacco Use Disorder Version 2

The Effects of Sedatives on Tobacco Use Disorder Version 2

Condition
Tobacco Smoking
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Smokes cigarettes daily for at least 2 years
  • * Afternoon expired breath carbon monoxide at least 5 ppm or morning urinary cotinine at least 100 ng/ml
  • * Negative urine drug screen for psychoactive drugs and negative breath alcohol
  • * Have an unstable medical condition or stable medical condition that would interact with study drug or participation, including chronic pulmonary disease, coronary artery disease, current brain tumor, current increased intracranial pressure or impaired consciousness
  • * History of serious head trauma or neurological disorder (e.g., seizure disorder)
  • * Have any of the following: hypertension (i.e., systolic \>140 mm Hg and/or diastolic \>90 mm Hg on three separate measures; systolic \>170 or diastolic \> 110 on any occasion), pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
  • * Use of drugs that would interact with study drug or increase risk of adverse events
  • * Among women, pregnancy or lactation

Ages Eligible for Study

21 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wake Forest University Health Sciences,

Merideth A Addicott, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2024-12