Nicotine Dependence Clinical Trial
Official title:
Medications Development for the Treatment of Cannabis Related Disorders
The primary objective of this application is to test the neurobehavioral mechanisms and effects of aprepitant as a new cessation agent for cannabis, tobacco or both.
Stress (emotional, physical, social) facilitates drug seeking behavior through the activation of the HPA axis, autonomic nervous system, and brain DA systems. Furthermore, alterations within several neuropeptide systems (CRF, Substance P, and others) also contribute to the role of stress in addiction. Central to this project is that anxiety and stress responses are modulated by substance P and its preferred target, the NK1 receptor. Therefore the aim of this pilot clinical trial is to determine the safety and efficacy of aprepitant (a neurokinin 1 (NK1) receptor antagonist). We hypothesize that the NK1 receptor antagonist, aprepitant, will be safe, tolerable and efficacious at reducing the withdrawal symptoms, cue craving, and reinforcement value for both cannabis and tobacco resulting from the cessation of either or both drugs. We will assess this hypothesis in the context of a carefully controlled human laboratory study in which subjects (N=72) will be randomized in a 3 x 2 factorial design to one of 3 behavioral conditions; a) withdrawn from both substances, b) withdrawn from tobacco only, or c) withdrawn from cannabis only, and to receive one of 2 medication dose conditions: placebo or aprepitant (160 mg/day). Medication will be administered for 5 days, followed by a cue challenge, choice procedure, and then a consequence (i.e., oral cannabis or a cigarette or money) also on day 5. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05176418 -
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
|
Early Phase 1 | |
| 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| Withdrawn |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 |
NCT01926626 -
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
|
Phase 2 | |
| Completed |
NCT01982110 -
A Mindfulness Based Application for Smoking Cessation
|
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 | |
| Completed |
NCT01569490 -
Striving to Quit: First Breath
|
N/A | |
| Completed |
NCT01632189 -
The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
|
N/A | |
| 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 | |
| Withdrawn |
NCT01589081 -
Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect
|
N/A | |
| Suspended |
NCT01636336 -
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
|
N/A | |
| Completed |
NCT01943994 -
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
|
N/A |