Early Phase 1
N=7
Ketamine and Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder
Tobacco Use · Smoking Cessation · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT05796791 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Feasibility of Ketamine Treatment for Tobacco Use Disorder — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ketamine Hydrochloride (Drug); Motivational enhancement therapy (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Ketamine Treatment for Tobacco Use Disorder |
7 | — |
| SECONDARY Smoking Cessation |
— | — |
| SECONDARY Reduction in Cigarettes Smoked Per Day |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 21 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT05796791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.