Sex Differences, Hormones & Smoking Cessation

NCT01744574 | Completed Results DMC

• 2 other identifiers: 2012NTLS074P50DA033942-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.

Conditions

Tobacco Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4

  7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4

  Week 4

Secondary Outcomes (6)

• Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12

  Weeks 8 and 12

• Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12

  Weeks 4, 8 and 12

• Number of Participants With Continuous Abstinence From Smoking at Week 12

  Week 12

• Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12

  Weeks 4, 8 and 12

• Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12

  Weeks 4, 8 and 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.

Other: Placebo; Other: Smoking Cessation Behavioral Counseling

Progesterone

EXPERIMENTAL

The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.

Drug: Progesterone; Other: Smoking Cessation Behavioral Counseling

Interventions

Placebo OTHER

Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.

Placebo

Progesterone DRUG

The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.

Also known as: Prometrium

Progesterone

Smoking Cessation Behavioral Counseling OTHER

Subjects will receive weekly smoking cessation behavioral counseling.

Placebo; Progesterone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male 18 to 60 years old
• Female 18 to 50 years old
• Self-report regular smoking
• Motivated to quit smoking
• In stable physical/mental health
• Self report of regular menstrual cycles (female only)
• English fluency
• Understand the study procedures and able to provide informed consent
• Ability to participate fully in research elements for the duration of the trial.

You may not qualify if:

• Current or recent (\< 3 months) breastfeeding (females only)
• Current or planned pregnancy within the next three months (females only)
• Conditions contraindicated to progesterone treatment.

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Delaware Clinical Research Unit, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Limitations and Caveats

Generalizability is limited as our sample included only premenopausal women. The sample size was too small to directly compare sex differences between men and women. Participants were only followed for 12 weeks.

Results Point of Contact

• Title: Dr. Sharon Allen
• Organization: University of Minnesota

allen001@umn.edu

612-624-0446

Study Officials

• Sharon S. Allen, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: July 12, 2019
• Results First Posted: December 28, 2018

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)