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Pexacerfont to Reduce Stress-induced Tobacco Craving

NCT01557556 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

\- Stressful situations often cause tobacco cravings. These cravings can make it very difficult for smokers who are trying to quit. Research has shown that craving may involve hormone pathways in the brain. The anti-anxiety drug pexacerfont acts on these hormone pathways. Researchers want to see if pexacerfont can act on the brain and lessen stress-related tobacco cravings in smokers who are trying to quit.

Objectives:

\- To test the effects of pexacerfont on tobacco craving in smokers who want to quit smoking.

Eligibility:

\- Smokers between 18 to 55 years of age who are trying to quit. (Participants must have smoked at least 10 cigarettes per day for at least 1 year.)

Design:

* Participants will be screened with a physical exam and medical history.
* Participants will be assigned to take either pexacerfont or a placebo. They will take three pills every morning for the first 7 days, then one pill every morning for 23 days.
* At the first visit, participants will provide blood and urine samples. They will then be asked to prepare a 5-minute speech and give it to the study researchers. They will also be asked to do mental math problems for another 5 minutes. During these tests, blood pressure, heart rate, sweating, and skin temperature will be measured. Participants will fill out questionnaires about stress levels, tobacco cravings, and personal experiences.
* Participants will take the study pills for 30 days. Before the 2-week point, participants will be asked to try to quit smoking for 2 weeks.
* Participants will have four study visits. These visits will involve brain imaging scans and emotional stress tests. Tobacco cravings and other stress levels will be measured at each study. Blood and urine samples may be collected at these studies.
* Participants will have follow-up visits and phone calls for up to 6 months after the end of the study visits.

Conditions

  • Nicotine Dependence

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Elliot Stein, Ph.D. · National Institute on Drug Abuse (NIDA)

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-24
Completion
2013-12-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557556 on ClinicalTrials.gov