Clinical trial

The Effects of Sedatives on Tobacco Use Disorder Version 2

Name

IRB00081012

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.

Trial arms

Trial start

2023-01-31

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Ketamine

A single dose of IV ketamine will be administered.

Arms:

Dexmedetomidine first injection; ketamine second injection, Ketamine first injection; Saline second injection, Ketamine first injection; dexmedetomidine second injection, Ketamine first injection; midazolam second injection, Midazolam first injection; ketamine second injection, Saline first injection; ketamine second injection

Other names:

a dissociative anesthetic used medically for induction and maintenance of anesthesia

Midazolam

A single dose of IV midazolam will be administered

Arms:

Dexmedetomidine first injection; midazolam second injection, Ketamine first injection; midazolam second injection, Midazolam first injection; Saline second injection, Midazolam first injection; dexmedetomidine second injection, Midazolam first injection; ketamine second injection, Saline first injection; midazolam second injection

Other names:

benzodiazepine medication

Dexmedetomidine

A single dose of IV dexmedetomidine will be administered

Arms:

Dexmedetomidine first injection; Saline second injection, Dexmedetomidine first injection; ketamine second injection, Dexmedetomidine first injection; midazolam second injection, Ketamine first injection; dexmedetomidine second injection, Midazolam first injection; dexmedetomidine second injection, Saline first injection; dexmedetomidine second injection

Other names:

benzodiazepine medication

Saline

A single dose of IV saline will be administered

Arms:

Dexmedetomidine first injection; Saline second injection, Ketamine first injection; Saline second injection, Midazolam first injection; Saline second injection, Saline first injection; dexmedetomidine second injection, Saline first injection; ketamine second injection, Saline first injection; midazolam second injection

Size

Primary endpoint

Difference in craving between drug and placebo

24-hours post infusion

Difference in tobacco withdrawal symptoms

24-hours post infusion

Difference in cigarette demand

24-hours post infusion

Number of cigarettes smoked ad lib

24-hours post infusion

Eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}

Updated at

2023-10-18

1 organization

2 products

2 drugs

1 indication

Organization

Wake Forest University Health Sciences

Drug

Indication

Product

Product

Drug