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The Effects of Sedatives on Tobacco Use Disorder Version 2

NCT ID: NCT05505630

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-12-10

Brief Summary

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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.

Detailed Description

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This double-blind, placebo-controlled, randomized mechanistic clinical trial will test non-treatment seeking smokers with an intravenous infusion of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or placebo, at least 2 weeks apart. Participants will complete 7-day ecological momentary assessment (EMA) of daily craving, withdrawal, and smoking behavior before and after each infusion. They will be asked to abstain from tobacco/nicotine for twenty-four hours post-infusion to induce withdrawal symptoms and return to the lab the following day to complete measures of craving, withdrawal, an MRI scan, and smoking latency. After this study visit, participants will be allowed to smoke as usual for the rest of the EMA diary period. Physical and subjective effects and adverse effects will be closely monitored throughout.

Conditions

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Tobacco Smoking

Keywords

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nicotine addiction smoking placebo sedatives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Saline first injection; ketamine second injection

Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion ketamine at the second injection visit.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of IV ketamine will be administered.

Saline

Intervention Type DRUG

A single dose of IV saline will be administered

Saline first injection; midazolam second injection

Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion midazolam at the second injection visit

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

A single dose of IV midazolam will be administered

Saline

Intervention Type DRUG

A single dose of IV saline will be administered

Saline first injection; dexmedetomidine second injection

Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

A single dose of IV dexmedetomidine will be administered

Saline

Intervention Type DRUG

A single dose of IV saline will be administered

Ketamine first injection; Saline second injection

Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion placebo at the second injection visit.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of IV ketamine will be administered.

Saline

Intervention Type DRUG

A single dose of IV saline will be administered

Ketamine first injection; midazolam second injection

Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of IV ketamine will be administered.

Midazolam

Intervention Type DRUG

A single dose of IV midazolam will be administered

Ketamine first injection; dexmedetomidine second injection

Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of IV ketamine will be administered.

Dexmedetomidine

Intervention Type DRUG

A single dose of IV dexmedetomidine will be administered

Midazolam first injection; Saline second injection

Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion placebo at the second injection visit.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

A single dose of IV midazolam will be administered

Saline

Intervention Type DRUG

A single dose of IV saline will be administered

Midazolam first injection; ketamine second injection

Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion ketamine at the second injection visit.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of IV ketamine will be administered.

Midazolam

Intervention Type DRUG

A single dose of IV midazolam will be administered

Midazolam first injection; dexmedetomidine second injection

Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

A single dose of IV midazolam will be administered

Dexmedetomidine

Intervention Type DRUG

A single dose of IV dexmedetomidine will be administered

Dexmedetomidine first injection; Saline second injection

Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion placebo at the second injection visit.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

A single dose of IV dexmedetomidine will be administered

Saline

Intervention Type DRUG

A single dose of IV saline will be administered

Dexmedetomidine first injection; ketamine second injection

Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion ketamine at the second injection visit.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of IV ketamine will be administered.

Dexmedetomidine

Intervention Type DRUG

A single dose of IV dexmedetomidine will be administered

Dexmedetomidine first injection; midazolam second injection

Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

A single dose of IV midazolam will be administered

Dexmedetomidine

Intervention Type DRUG

A single dose of IV dexmedetomidine will be administered

Interventions

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Ketamine

A single dose of IV ketamine will be administered.

Intervention Type DRUG

Midazolam

A single dose of IV midazolam will be administered

Intervention Type DRUG

Dexmedetomidine

A single dose of IV dexmedetomidine will be administered

Intervention Type DRUG

Saline

A single dose of IV saline will be administered

Intervention Type DRUG

Other Intervention Names

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a dissociative anesthetic used medically for induction and maintenance of anesthesia benzodiazepine medication benzodiazepine medication

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nida Addiction Research Center

UNKNOWN

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merideth A Addicott, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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10595

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00081012

Identifier Type: -

Identifier Source: org_study_id