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

NCT05796791 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: Pro00126022
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use; Smoking Cessation; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Smoking Cessation

  Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8

• Reduction in Cigarettes Smoked Per Day

  Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8

Study Arms (1)

Treatment of tobacco use disorder with ketamine

EXPERIMENTAL

Drug: Ketamine Hydrochloride; Behavioral: Motivational enhancement therapy

Interventions

Ketamine Hydrochloride DRUG

IM ketamine given in weekly session for a total of 3 weeks

Treatment of tobacco use disorder with ketamine

Motivational enhancement therapy BEHAVIORAL

Brief motivational based therapy

Treatment of tobacco use disorder with ketamine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old.
• Able to provide informed consent.
• Be a daily cigarette smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking.
• Agree to abstain from smoking for the ketamine session from 1 hour before ketamine administration
• Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of ketamine administration. Exceptions include caffeine and nicotine.
• Subjects taking other psychotropic medications must be maintained on a stable dose for at least four weeks before study initiation.
• 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.
• 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.

You may not qualify if:

• 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
• Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders or current depression or bipolar disorder based on clinical interview.
• Subjects meeting DSM-5 criteria for current substance use disorder other than tobacco use disorder.
• Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) \>140 mmHg or a diastolic blood pressure (DBP) \>90 mmHg.
• A history of allergic or other adverse reaction to ketamine (or its excipients).
• 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).
• 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
• Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study.
• Subjects with clinically significant kidney or liver impairment.
• 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.
• Morbidly obese (BMI \>40), or severely underweight as determined by medical examination.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

Location

MeSH Terms

Conditions

Tobacco Use; Smoking Cessation; Tobacco Use Disorder

Interventions

Ketamine; Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Emily Amador
• Organization: Medical University of South Carolina

emmcamador@gmail.com

916-279-6481

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Study

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: May 2, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-07

Locations

US (1)