The Effects of Sedatives on Tobacco Use Disorder

NCT03813121 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB000229077
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  about 1 week post infusion

Study Arms (3)

midazolam intravenous infusion

EXPERIMENTAL

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

Drug: midazolam intravenous infusion

placebo intravenous infusion

PLACEBO COMPARATOR

single placebo infusion (saline over 20 minutes)

Drug: placebo intravenous infusion

ketamine intravenous infusion

EXPERIMENTAL

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

Drug: ketamine intravenous infusion

Interventions

midazolam intravenous infusion DRUG

Participants will receive a single drug infusion

midazolam intravenous infusion

placebo intravenous infusion DRUG

Participants will receive a single placebo infusion

placebo intravenous infusion

ketamine intravenous infusion DRUG

Participants will receive a single drug infusion

ketamine intravenous infusion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

The planned enrollment was 12 people. Investigator decided to complete the study early at 10 people because the principal investigator was leaving the institution and the logistics of running this remotely were too difficult. The last participant's last visit occurred, no new subjects were enrolled

Results Point of Contact

• Title: Dr. Merideth Addicott
• Organization: Wake Forest University School of Medicine

maddicot@wakehealth.edu

336-716-7792

Study Officials

• Merideth Addicott, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: June 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 6, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)