Nicotine Dependence, Smoking Cessation, Tobacco Use
Conditions
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.
Interventions
DRUGKetamine Hydrochloride
IM ketamine given in weekly session for a total of 3 weeks
BEHAVIORALMotivational enhancement therapy
Brief motivational based therapy
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot Study
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 21 to 65 years old. 2. Able to provide informed consent. 3. Be a daily cigarette smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking. 4. Agree to abstain from smoking for the ketamine session from 1 hour before ketamine administration 5. Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of ketamine administration. Exceptions include caffeine and nicotine. 6. Subjects taking other psychotropic medications must be maintained on a stable dose for at least four weeks before study initiation. 7. 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. 8. 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
1. 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 2. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders or current depression or bipolar disorder based on clinical interview. 3. Subjects meeting DSM-5 criteria for current substance use disorder other than tobacco use disorder. 4. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) \>140 mmHg or a diastolic blood pressure (DBP) \>90 mmHg. 5. A history of allergic or other adverse reaction to ketamine (or its excipients). 6. 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). 7. 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 8. Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study. 9. Subjects with clinically significant kidney or liver impairment. 10. 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. 11. Morbidly obese (BMI \>40), or severely underweight as determined by medical examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Ketamine Treatment for Tobacco Use Disorder | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8 | 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 |
| Reduction in Cigarettes Smoked Per Day | Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8 | Evaluate if there is reduction in cigarettes smoked per day via the self-reported time-line follow back |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment of Tobacco Use Disorder With Ketamine Ketamine Hydrochloride: IM ketamine given in weekly session for a total of 3 weeks
Motivational enhancement therapy: Brief motivational based therapy | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Treatment of Tobacco Use Disorder With Ketamine |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 12.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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.
Time frame: 8 weeks
Population: Number of participants enrolled that completed all three interventional sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment of Tobacco Use Disorder With Ketamine | Feasibility of Ketamine Treatment for Tobacco Use Disorder | 7 Participants |
Secondary
Reduction in Cigarettes Smoked Per Day
Evaluate if there is reduction in cigarettes smoked per day via the self-reported time-line follow back
Time frame: Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8
Secondary
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
Time frame: Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8