Ketamine and Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder

The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for tobacco use disorder when delivered in conjunction with brief motivational enhancement therapy. Participants will receive ketamine assisted motivational enhancement therapy weekly for three weeks and there will be 2 follow up visits. All visits will also consist of questionnaires and saliva samples will be taken. The overall participation will last approximately 8 weeks.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Tobacco Use; Nicotine Dependence
• Intervention / Treatment: Drug: Ketamine Hydrochloride; Behavioral: Motivational enhancement therapy

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Emily C Amador, DO; Phone Number: 843-608-1216; Email: amador@musc.edu
• Study Contact Backup: Name: Jennifer Jones, MD; Email: jonjen@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Recruiting
      • Medical University of South Carolina
      • Contact: Emily Amador, D.O.; Phone Number: 651-387-9787; Email: amador@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 21 to 65 years old.
2. Able to provide informed consent.
3. Be a daily cigarette smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking.
4. Agree to abstain from smoking for the ketamine session from 1 hour before ketamine administration
5. Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of ketamine administration. Exceptions include caffeine and nicotine.
6. Subjects taking other psychotropic medications must be maintained on a stable dose for at least four weeks before study initiation.
7. Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG) to verify normal QTc intervals.
8. Subjects with normal blood pressure not on antihypertensive medications or medication controlled hypertension as defined baseline visit systolic blood pressure (SBP) <140 mmHg or a diastolic blood pressure (DBP) <90 mmHg.

Exclusion Criteria:

1. Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control which can include oral, implant, intrauterine device, or patch contraceptive methods as well as barrier contraceptive methods, history of surgery such as hysterectomy or tubal ligation, or abstinence
2. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders or current depression or bipolar disorder based on clinical interview.
3. Subjects meeting DSM-5 criteria for current substance use disorder other than tobacco use disorder.
4. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
5. A history of allergic or other adverse reaction to ketamine (or its excipients).
6. Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).
7. Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease
8. Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study.
9. Subjects with clinically significant kidney or liver impairment.
10. Have any current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma, or CNS tumor.
11. Morbidly obese (BMI >40), or severely underweight as determined by medical examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment of tobacco use disorder with ketamine	Drug: Ketamine Hydrochloride; IM ketamine given in weekly session for a total of 3 weeks; Behavioral: Motivational enhancement therapy; Brief motivational based therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of ketamine treatment for tobacco use disorder	The primary outcome of this study will be the feasibility of using ketamine-assisted treatment for smoking cessation, which will assess the number of people selected for randomization that complete the full treatment. This will help determine if the treatment of ketamine in tobacco use would be beneficial for further study.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	Saliva cotinine levels will be collected prior to each ketamine session and at each follow up to detect smoking over approximately the past 6 days	Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8
Reduction in cigarettes smoked per day	Evaluate if there is reduction in cigarettes smoked per day via the self-reported time-line follow back	Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Pro00126022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No