Enhancing Self Regulation Among Smokers

NCT04161144 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 76669
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Smoking, Cigarette; Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• Craving Levels in Response to Cue

  Patients are asked about craving level on a scale of 0-100, 0 is least amount of craving and 100 is highest amount of craving

  Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)

• Heart Rate in Response to Cue

  Heart rate is measured using a Biopac machine and Acqknowledge software at different timepoints throughout each visit while the participants are exposed to smoking cues.

  Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)

Secondary Outcomes (1)

• Average Cigarettes Smoked Per Day

  Visit 1 through Visit 3 (day 0-day 14)

Study Arms (2)

Rapamycin 15mg (sirolimus)

ACTIVE COMPARATOR

Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.

Drug: sirolimus

Placebo

PLACEBO COMPARATOR

Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.

Drug: Placebo

Interventions

sirolimus DRUG

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

Also known as: rapamycin, rapamune

Rapamycin 15mg (sirolimus)

Placebo DRUG

Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must smoke 10+ cigarettes/day for three or more years
• Have a Fagerström Test for Nicotine Dependence score greater than or equal to 4
• Be willing to make a cessation attempt
• Willing to comply with reinforced abstinence requirements for the three laboratory sessions
• Willing to use appropriate birth control methods during study participation including oral contraceptives, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse
• Remain abstinent from alcohol and all non-prescription drugs prior to medication administration and testing sessions
• Live with within a 50 mile radius of our research program and have reliable transportation
• Consent to fast for a two-hour period prior to medication administration
• Consent to random assignment to rapamycin (sirolimus) vs. placebo conditions

You may not qualify if:

• Dependence on other substances (may meet criteria for abuse)
• Undergoing other smoking cessation treatment (e.g., nicotine replacement, Chantix)
• Taking medications that may interact with the study medication or alter responding on any study measure
• Are pregnant, nursing, or of childbearing potential and not using birth control
• Present evidence of or a history of significant endocrine, cardiovascular, pulmonary, renal or neurological disease, as these conditions may affect heart rate or skin conductance measurement
• Have significant liver impairment (as indicated by alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values that are three times the upper limit of normal) as rapamycin (sirolimus) is hepatically metabolized
• Have an existing infection or immune system disorder as rapamycin (sirolimus) has known immunosuppressive properties
• Have a history of or current psychotic disorder, severe major depression as evidenced by active and profound psychomotor retardation and/or persistent and intense suicidal ideation
• Currently taking anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring
• Have known or suspected hypersensitivity to macrolide compounds (such as rapamycin/sirolimus)
• Taking medications that could adversely interact with study medication including but not limited to significant inhibitors of CYP2D6 or CYP3A4 (voriconazole, fluconazole, itraconazole, erythromycin, clarithromycin, diltiazem, verapamil, etc.) or significant inducers of CYP3A4, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.) and antibiotics (rifabutin, rifapentine, etc.)
• Have a history of thrombocytopenia, idiopathic thrombocytopenia purpura (ITP), or with a current platelet count of less than 100,000 cells per mm3,
• Have any unhealed wounds, including but not limited to oral ulcers, foot ulcers, or recent surgical or trauma wounds
• Have any planned surgeries within the next month, including surgical dental procedures

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking; Tobacco Use Disorder

Interventions

Sirolimus; Sugars

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Michael Saladin
• Organization: Medical University of South Carolina

saladinm@musc.edu

8437925306

Study Officials

• Michael Saladin, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: October 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)