Trial Outcomes & Findings for Ketamine and Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder (NCT NCT05796791)

Last Updated: 2025-07-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

7 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment of Tobacco Use Disorder With Ketamine n=7 Participants Ketamine Hydrochloride: IM ketamine given in weekly session for a total of 3 weeks Motivational enhancement therapy: Brief motivational based therapy
Age, Continuous	46 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Number of participants enrolled that completed all three interventional sessions.

Outcome measures

Outcome measures
Measure	Treatment of Tobacco Use Disorder With Ketamine n=7 Participants Ketamine Hydrochloride: IM ketamine given in weekly session for a total of 3 weeks Motivational enhancement therapy: Brief motivational based therapy
Feasibility of Ketamine Treatment for Tobacco Use Disorder	7 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Treatment of Tobacco Use Disorder With Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emily Amador

Medical University of South Carolina

Phone: 916-279-6481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place