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NMDA receptor antagonist

Ketamine + Motivational Enhancement Therapy for Smoking Cessation

Phase < 1
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, treatment week 1, 2, 3, and follow up week 4, and 8
Awards & highlights

Study Summary

This trial will examine if an investigational drug (ketamine) combined with therapy can help people quit smoking. It will involve 8 weeks of visits, questionnaires, and saliva samples.

Who is the study for?
This trial is for adults aged 21-65 who smoke cigarettes daily, have tried to quit multiple times, and want to stop smoking. They must be in good health, not use psychoactive drugs or alcohol before sessions, and have stable blood pressure. Pregnant women or those with certain medical conditions like uncontrolled hypertension or a history of allergic reactions to ketamine are excluded.Check my eligibility
What is being tested?
The study tests if ketamine can help people with tobacco use disorder quit smoking when combined with motivational enhancement therapy. Participants will undergo this combination treatment weekly for three weeks plus two follow-up visits involving questionnaires and saliva samples over about eight weeks.See study design
What are the potential side effects?
Ketamine may cause side effects such as increased blood pressure, disorientation, changes in mood or behavior, nausea, dizziness, blurred vision, and potentially addictive tendencies. The severity of these side effects can vary among individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, treatment week 1, 2, 3, and follow up week 4, and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, treatment week 1, 2, 3, and follow up week 4, and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of ketamine treatment for tobacco use disorder
Secondary outcome measures
Reduction in cigarettes smoked per day
Smoking cessation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment of tobacco use disorder with ketamineExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1000
Motivational enhancement therapy
2008
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,628 Total Patients Enrolled
9 Trials studying Tobacco Use
42,360 Patients Enrolled for Tobacco Use

Media Library

Ketamine Hydrochloride (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05796791 — Phase < 1
Tobacco Use Research Study Groups: Treatment of tobacco use disorder with ketamine
Tobacco Use Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05796791 — Phase < 1
Ketamine Hydrochloride (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796791 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current research endeavor actively seeking participants?

"The public record on clinicaltrials.gov reveals that this investigation is still looking for participants. Initially posted on May 2nd 2023, the study was updated most recently at the end of June."

Answered by AI

Does this research endeavor only include individuals over a certain age?

"The age range for this clinical trial is restricted to 21-65 year olds. Conversely, there are 19 trials that accept minors and 229 studies available for seniors."

Answered by AI

Who has the opportunity to join this research project?

"To qualify for this study, potential participants must be nicotine dependent and of an age between 21 to 65 years old. Up to 8 people will have the chance to join in on this trial."

Answered by AI

What is the enrollment capacity of this scientific investigation?

"Affirmative. Clinicaltrials.gov documents this medical experiment as being open for recruitment, with the original post dating back to May 2nd 2023 and last updated on June 28th 2023. The study is currently searching for 8 individuals from 1 location."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~0 spots leftby May 2024