Nicotine Dependence Clinical Trial
Official title:
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 55 Years |
Eligibility | Inclusion Criteria: - Female and male, aged 21 to 55 years; - past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests - women, -using acceptable birth control methods. Exclusion Criteria: - History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study - risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD - regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) - current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine - for women, pregnant as determined by pregnancy screening, or breast feeding - seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid. |
Country | Name | City | State |
---|---|---|---|
United States | VA Healthcare System | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drug Effects Questionnaire mean score | The DEQ measures Good Drug Effect and consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects. | up to five years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04084210 -
Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use
|
Phase 2 | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Withdrawn |
NCT03707600 -
State and Trait Mediated Response to TMS in Substance Use Disorder
|
N/A | |
Recruiting |
NCT03999099 -
Targeting Orexin to Treat Nicotine Dependence
|
Phase 1 | |
Completed |
NCT03847155 -
Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
|
N/A | |
Completed |
NCT02840435 -
Study on Sit to Quit Phone Intervention
|
N/A | |
Completed |
NCT02139930 -
Project 2: Strategies for Reducing Nicotine Content in Cigarettes
|
N/A | |
Completed |
NCT01982110 -
A Mindfulness Based Application for Smoking Cessation
|
N/A | |
Completed |
NCT01926626 -
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
|
Phase 2 | |
Completed |
NCT01569490 -
Striving to Quit: First Breath
|
N/A | |
Completed |
NCT01632189 -
The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
|
N/A | |
Completed |
NCT01685996 -
Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
|
Phase 1/Phase 2 | |
Withdrawn |
NCT01569477 -
Striving to Quit-Wisconsin Tobacco Quit Line
|
N/A | |
Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
Completed |
NCT00996034 -
Nicotine Vaccination and Nicotinic Receptor Occupancy
|
Phase 2 | |
Completed |
NCT01061528 -
Coping Skills Treatment for Smoking Cessation
|
N/A | |
Withdrawn |
NCT01589081 -
Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect
|
N/A | |
Completed |
NCT01943994 -
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
|
N/A | |
Suspended |
NCT01636336 -
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
|
N/A | |
Withdrawn |
NCT00571805 -
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
|
Phase 1/Phase 2 |