The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking

NCT01576874 | Completed Results DMC

• 2 other identifiers: Pro00016931P50DA016511
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the overall parent study is to determine the impact of gender and hormones (estradiol, progesterone, testosterone and cortisol) on responses to stress and smoking cues presented in daily, "real-world" cue presentations compared to a final cue session in a lab. In addition, in the portion of the study that incorporates clinical trials elements and is reported here, the study will examine the impact of a single dose of oxytocin (chemical produced in the body) versus placebo (inactive substance) on reactivity to a stress procedure (Trier Social Stress Task) in smokers. The overall parent study involves a cue presentation technology known as "CREMA" (Cue Reactivity Ecologic Momentary Assessment) which delivers four daily cue presentations to you on a handheld device during your everyday routine. Additionally, the study involves daily collection of saliva samples for hormonal testing. These daily procedures will provide information about the role of cues and hormones in daily life. The clinical trial portion of the study (reported here) consists of measures collected within the laboratory.

Conditions

Nicotine Dependence

Keywords

nicotine dependence; hormones

Outcome Measures

Primary Outcomes (1)

• Craving Response to Trier Social Stress Task

  The TSST is the gold standard for evoking stress response in the laboratory. The participant must deliver a speech as though speaking to a group of hiring managers. The participant has 5 min to prepare, then three individuals unfamiliar to the participant (the audience) enter the room and are seated; the participant is instructed give the speech (without notes). The speech is delivered for 5 min, then the participant is instructed to serially subtract 13 from 1,022 as quickly and accurately as possible. The mental math recitation continues for 5 min, and at its conclusion, the spokesperson instructs the participant to stop and be seated, and the audience leaves the room. The total time for the TSST is 15 min. The Craving Questionnaire (Carter \& Tiffany, 2001) is the sum of 4 items, each rated 1-5 on a Likert scale, with total score ranging 4-20, and higher scores indicating higher craving.

  Immediately after the conclusion of the TSST

Secondary Outcomes (2)

• Stress Response to Trier Social Stress Task

  Immediately after the conclusion of the TSST

• Cortisol Response to Trier Social Stress Task

  Immediately following the Trier Social Stress Task

Study Arms (2)

oxytocin

EXPERIMENTAL

Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.

Drug: Oxytocin

placebo

PLACEBO COMPARATOR

Participants will be administered 40 IUs of placebo nasal spray at one study visit.

Drug: placebo

Interventions

Oxytocin DRUG

40 IUs of oxytocin administered intranasally one time

Also known as: syntocinon

oxytocin

placebo DRUG

placebo administered intranasally one time

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months
• Females must be post menarche and pre-menopausal, have a regular menstrual cycle between 25 and 35 days, and, if recently pregnant, be at least three months post-delivery/breast feeding
• Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit

You may not qualify if:

• Any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion
• Participants must not meet criteria for PTSD
• Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring
• Current substance dependence other than nicotine and caffeine use, in the past month
• Use of other tobacco products
• Females must not be pregnant, breast feeding, status post hysterectomy or bilateral oophorectomy, or taking birth control or hormone replacement medication that would affect the menstrual cycle
• Males must not be status post orchiectomy

Sponsors & Collaborators

• Kevin Gray, MD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

843-792-6330

Study Officials

• Michael Saladin, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Kevin M Gray, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 13, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 1, 2020
• Results First Posted: December 17, 2018

Record last verified: 2020-06

Locations

US (1)