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.
Seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. Across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. In each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. While receiving the pulsed infusions, participants will inhale a tobacco-flavored EC without nicotine, which will allow for a closer matching of the sensory aspects of inhaled tobacco use. There are four pulse duration conditions for the nicotine sessions: 2-, 4-, 6- and 8-second pulses. For those assigned to 1.0 mg/70kg nicotine dose, the pulse duration conditions correspond to nicotine delivery rates of 50, 25, 16.6, and 12.5 mcg nicotine/second. For those assigned to 0.2 mg/70 kg dose, the corresponding delivery rates will be 10, 5, 3.3 and 2.5 mcg nicotine/second. Participants in both nicotine dose groups will each have one placebo test session wherein they will receive 10 pulsed-saline infusions. ;
| 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| Withdrawn |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 | |
| Withdrawn |
NCT01569477 -
Striving to Quit-Wisconsin Tobacco Quit Line
|
N/A | |
| Completed |
NCT01685996 -
Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
| Completed |
NCT01061528 -
Coping Skills Treatment for Smoking Cessation
|
N/A | |
| Completed |
NCT00996034 -
Nicotine Vaccination and Nicotinic Receptor Occupancy
|
Phase 2 | |
| Suspended |
NCT01636336 -
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
|
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 | |
| Withdrawn |
NCT00571805 -
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt
|
Phase 1/Phase 2 |