N/A
Completed N=216
Sex Differences, Hormones & Smoking Cessation
Tobacco Cessation
Source: ClinicalTrials.gov NCT01744574 ↗
Enrolled (actual)
216
Serious AEs
0.5%
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4 — 12; 13; 9; 18 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4 |
12; 13; 9; 18 | — |
| SECONDARY Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12 |
10; 10; 10; 16; 12; 7 | — |
| SECONDARY Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12 |
15; 11; 10; 18; 9; 7 | — |
| SECONDARY Number of Participants With Continuous Abstinence From Smoking at Week 12 |
4; 4; 2; 8 | — |
| SECONDARY Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12 |
9; 11; 8; 10; 7; 8 | — |
| SECONDARY Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12 |
17; 20; 18; 22; 14; 13 | — |
| SECONDARY Average Number of Days to Relapse |
13.3; 13.4; 14.3; 20.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Current or recent (< 3 months) breastfeeding (females only)
- Current or planned pregnancy within the next three months (females only)
- Conditions contraindicated to progesterone treatment.
Data sourced from ClinicalTrials.gov (NCT01744574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.