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

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ClinicalTrials.gov Identifier: NCT03813121
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
side effects [ Time Frame: about 1 week post infusion ]
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. Mean subscales scored separately. Higher scores indicate worse outcome (range 1 to 7).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Sedatives on Tobacco Use Disorder
Official Title  ICMJE The Effects of Sedatives on Tobacco Use Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
single-blind
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • Drug: midazolam intravenous infusion
    Participants will receive a single drug infusion
  • Drug: placebo intravenous infusion
    Participants will receive a single placebo infusion
  • Drug: ketamine intravenous infusion
    Participants will receive a single drug infusion
Study Arms  ICMJE
  • Experimental: midazolam intravenous infusion
    single midazolam infusion (0.02 mg/kg over 20 minutes)
    Intervention: Drug: midazolam intravenous infusion
  • Placebo Comparator: placebo intravenous infusion
    single placebo infusion (saline over 20 minutes)
    Intervention: Drug: placebo intravenous infusion
  • Experimental: ketamine intravenous infusion
    single ketamine infusion (0.5 mg/kg over 20 minutes)
    Intervention: Drug: ketamine intravenous infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Merideth Addicott, PhD 5015268436 MAddicott@uams.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03813121
Other Study ID Numbers  ICMJE 229077
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Merideth Addicott, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP