Clinical TrialTobacco/Nicotine Use Disorder (TUD)KetamineCompleted

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

Single-group pilot interventional study (n=7) evaluating IM ketamine administered weekly for three weeks combined with brief motivational enhancement therapy for tobacco use disorder.

Target Enrollment
7 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

The purpose of this study is to examine whether ketamine improves treatment outcomes for tobacco use disorder when delivered with brief motivational enhancement therapy. Participants receive IM ketamine once weekly for three weeks paired with a brief motivational enhancement therapy session.

Assessments include questionnaires and saliva samples at each visit; there are two follow-up visits and overall participation lasts approximately eight weeks.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Therapeutic Protocol

mi

Study Arms & Interventions

Ketamine + MET

experimental

IM ketamine weekly for 3 weeks combined with brief motivational enhancement therapy.

Interventions

  • Ketamine
    via IM• weekly• 3 doses total

    IM ketamine administered weekly for 3 sessions.

  • Compound
    via Other• weekly• 3 doses total

    Brief motivational enhancement therapy delivered alongside each ketamine session.

Participants

Ages
21 – 65
Sexes
Male & Female

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

  • 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.

Study Details

Locations

Medical University of South Carolina — Charleston, South Carolina, United States

Your Library