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The Effects of Sedatives on Tobacco Use Disorder (SED-TUD)

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
midazolam intravenous infusion
placebo intravenous infusion
ketamine intravenous infusion
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • smoke at least 5 cigarettes per day
  • smoked at least 2 years
  • negative urine drug screen for psychoactive drugs and negative breath alcohol concentration
  • live in Little Rock AR or surrounding area

Exclusion Criteria:

  • unstable or stable medical condition that would interact with study medication or participation
  • serious head trauma or neurological disorder
  • hypertension, abnormal ECG or metabolic blood results
  • meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder
  • use of psychoactive drugs or medications
  • BMI > 40
  • among women, pregnancy or breastfeeding

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

midazolam intravenous infusion

placebo intravenous infusion

ketamine intravenous infusion

Arm Description

single midazolam infusion (0.02 mg/kg over 20 minutes)

single placebo infusion (saline over 20 minutes)

single ketamine infusion (0.5 mg/kg over 20 minutes)

Outcomes

Primary Outcome Measures

Side Effects
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2019
Last Updated
September 28, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03813121
Brief Title
The Effects of Sedatives on Tobacco Use Disorder
Acronym
SED-TUD
Official Title
The Effects of Sedatives on Tobacco Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single-blind
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
midazolam intravenous infusion
Arm Type
Experimental
Arm Description
single midazolam infusion (0.02 mg/kg over 20 minutes)
Arm Title
placebo intravenous infusion
Arm Type
Placebo Comparator
Arm Description
single placebo infusion (saline over 20 minutes)
Arm Title
ketamine intravenous infusion
Arm Type
Experimental
Arm Description
single ketamine infusion (0.5 mg/kg over 20 minutes)
Intervention Type
Drug
Intervention Name(s)
midazolam intravenous infusion
Intervention Description
Participants will receive a single drug infusion
Intervention Type
Drug
Intervention Name(s)
placebo intravenous infusion
Intervention Description
Participants will receive a single placebo infusion
Intervention Type
Drug
Intervention Name(s)
ketamine intravenous infusion
Intervention Description
Participants will receive a single drug infusion
Primary Outcome Measure Information:
Title
Side Effects
Description
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Time Frame
about 1 week post infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: smoke at least 5 cigarettes per day smoked at least 2 years negative urine drug screen for psychoactive drugs and negative breath alcohol concentration live in Little Rock AR or surrounding area Exclusion Criteria: unstable or stable medical condition that would interact with study medication or participation serious head trauma or neurological disorder hypertension, abnormal ECG or metabolic blood results meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder use of psychoactive drugs or medications BMI > 40 among women, pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merideth Addicott, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Sedatives on Tobacco Use Disorder

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