NCT04161144

Enhancing Self Regulation Among Smokers

Enhancing Self-regulation by Altering Memories That Increase Risk of Relapse Among Smokers: A Translational Clinical Neuroscience Study of a Novel Medication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Smoking Cessation
• Smoking, Cigarette
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	sirolimus	Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
DRUG	Placebo	Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2019-11-13
• Last updated: 2021-03-09
• Results posted: 2021-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study