CompletedEarly Phase 1

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

United States7 participantsStarted 2023-05-02

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

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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.

Exclusion criteria

What they're measuring

Feasibility of Ketamine Treatment for Tobacco Use Disorder

Timeframe: 8 weeks

Trial details

NCT IDNCT05796791

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

Results submitted2025-06-12

View on ClinicalTrials.gov More Tobacco Use trials