Enhancing Self Regulation Among Smokers

Status Completed

Clinical Trial Summary

The purpose of this study is to examine the effects of rapamycin (sirolimus) versus a placebo, an inactive substance, on responses to smoking cues in individuals with nicotine dependence. Rapamycin (sirolimus) is a FDA-approved antibiotic and immunosuppressive drug that is currently used to (a) prevent organ transplant recipients from rejecting their transplants (b) treat cardiovascular diseases, and (c) treat some forms of cancer. Rapamycin (sirolimus) is not FDA-approved for smoking cessation. The use of rapamycin (sirolimus) in this study is investigational, meaning that the study medication is not a proven treatment for nicotine dependence, however this study will examine the medication's use as a potential future treatment for nicotine dependence.

Clinical Trial Description

The proposed study will employ 58 ND treatment-seeking smokers who will be randomly assigned to receive either 15-mg of sirolimus or placebo (group n's=29) immediately after the first of two smoking cue exposure sessions scheduled to occur on consecutive days. The first session will serve as a Retrieval session during which smoking (e.g., handling and lighting of a cigarette) cue exposure will elicit retrieval and reconsolidation of smoking-related memories; the second session will be a Test session to examine the potential modulatory role of sirolimus on the reconsolidation of memories putatively elicited during the retrieval session. Participants will be required to refrain from smoking the night before (bedtime) their first laboratory (i.e., Retrieval) session and will remain abstinent from smoking until the completion of the second laboratory (i.e., Test) session. It is posited that changes in reactivity during the test session will reflect medication effects on memory reconsolidation that occurred following the retrieval session. Measures of subjective responses (i.e., craving) and physiological reactivity (i.e., heart rate & skin conductance) will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed 7-days following completion of the test session. Treatment effects on self-report measures of smoking behavior during the 7-days preceding the Follow-up session will also be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04161144
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	Phase 2
Start date	October 1, 2018
Completion date	December 20, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04617444` - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function	N/A
Completed	`NCT02796391` - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes	Phase 2
Completed	`NCT03397511` - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City	N/A
Not yet recruiting	`NCT05188287` - A Culturally Tailored Smartphone Application for African American Smokers	N/A
Recruiting	`NCT05264428` - The Effect of Honey on Lessening the Withdrawal Symptoms	N/A
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	N/A
Completed	`NCT04133064` - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study	N/A
Completed	`NCT03187730` - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants	Phase 4
Completed	`NCT03474783` - To Explore the Factors Affecting the Effectiveness of Smoking Cessation	N/A
Completed	`NCT04635358` - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center	N/A
Terminated	`NCT03670264` - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation	N/A
Completed	`NCT02997657` - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial	N/A
Completed	`NCT03206619` - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed	`NCT02905656` - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit	N/A
Completed	`NCT02562521` - A Smoking Cessation Intervention for Yale Dining Employees	Phase 4
Completed	`NCT02239770` - Pharmacokinetics of Nicotine Film in Smokers	N/A
Recruiting	`NCT02422914` - Benefits of Tobacco Free Cigarette	N/A
Enrolling by invitation	`NCT02218944` - Smoking Response Inhibition Training	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Enhancing Self Regulation Among Smokers — MIMIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms