Tobacco UseEarly Phase 1NCT05796791
Ketamine and Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder
A Early Phase 1 study testing Ketamine Hydrochloride and Motivational enhancement therapy in people with Tobacco Use and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Smoking Cessation, Nicotine Dependence
- What is being tested?
- Ketamine Hydrochloride and Motivational enhancement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 30 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29412
About this study
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
- Being tested
- Ketamine Hydrochloride, Motivational enhancement therapy
- Medical subject headings
- Tobacco Use, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
IM ketamine given in weekly session for a total of 3 weeks
Motivational enhancement therapyBehavioural
Brief motivational based therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment of tobacco use disorder with ketamine | Experimental | Not described Receives: Drug: Ketamine Hydrochloride; Behavioral: Motivational enhancement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start2 May 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796791
- Sponsor's protocol ID
- Pro00126022
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2023
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder
- ClinicalTrials.gov ID
- NCT05796791
- Acronym / sponsor ID
- Pro00126022
- Conditions
- Tobacco Use, Smoking Cessation, Nicotine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Treatment of tobacco use disorder with ketamine | Experimental | Drug: Ketamine Hydrochloride, Behavioral: Motivational enhancement therapy |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideIM ketamine given in weekly session for a total of 3 weeks | Drug | Treatment of tobacco use disorder with ketamine |
| Motivational enhancement therapyBrief motivational based therapy | Behavioural | Treatment of tobacco use disorder with ketamine |
Primary outcome
Feasibility of Ketamine Treatment for Tobacco Use Disorder
Time frame: 8 weeks
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.
2 secondary outcomes
Smoking Cessation
Time frame: Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8
Reduction in Cigarettes Smoked Per Day
Time frame: Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine Hydrochloride and Motivational enhancement therapy in people with Tobacco Use and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Ketamine Treatment for Tobacco Use Disorder (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.