Phase 4
Completed N=66
Progesterone and Brain Imaging Study
Nicotine Dependence · Nicotine Withdrawal
Source: ClinicalTrials.gov NCT01954966 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) — 1.23; 1.17; 1.28; 1.24 mg/dl
◆ Published Evidence
Emerging
12citations · ~3 / year
Progesterone Increases Nicotine Withdrawal and Anxiety in Male but Not Female Smokers During Brief Abstinence.
Summary
Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
Linked Publications (2)
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Progesterone Increases Nicotine Withdrawal and Anxiety in Male but Not Female Smokers During Brief Abstinence.
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Effect of progesterone administration in male and female smokers on nicotine withdrawal and neural response to smoking cues: role of progesterone conversion to allopregnanolone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) |
1.23; 1.17; 1.28; 1.24; 1.21; 1.17 | — |
| PRIMARY GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) |
1.18; 1.20; 1.05; 0.98; 1.06; 1.11 | — |
| SECONDARY Symptoms During Nicotine Abstinence (NWSC) |
6.00; 6.15; 4.84; 4.48; 5.67; 4.92 | — |
| SECONDARY Brief Questionnaire on Smoking Urges (BQSU) |
40.89; 41.94; 30.45; 25.77; 38.47; 34.34 | — |
| SECONDARY Tiffany Questionnaire on Smoking Urges (TQSU) |
143.45; 140.31; 138.46; 140.77; 139.11; 135.88 | — |
| SECONDARY Profile of Mood States (POMS) Subscale: Tension-Anxiety |
2.88; 2.57; 3.55; 3.11; 4.85; 3.70 | — |
| SECONDARY Profile of Mood States (POMS) Subscale: Depression-Dejection |
1.09; 0.64; 1.30; 0.88; 1.66; 1.81 | — |
| SECONDARY Profile of Mood States (POMS) Subscale: Anger-Hostility |
0.94; 0.83; 1.55; 1.41; 2.70; 2.36 | — |
| SECONDARY Profile of Mood States (POMS) Subscale: Fatigue |
2.17; 1.77; 2.84; 3.63; 3.66; 3.10 | — |
| SECONDARY Profile of Mood State (POMS) Subscale: Vigor |
18.71; 18.71; 16.74; 16.73; 16.71; 16.39 | — |
| SECONDARY Profile of Mood States (POMS) Subscale: Confusion-Bewilderment |
2.47; 2.31; 2.95; 2.98; 3.46; 2.80 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Headache |
6.50; 7.59; 5.74; 9.39; 9.15; 14.71 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Hunger |
34.60; 40.23; 28.63; 22.20; 24.88; 33.40 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Nauseous |
5.52; 4.92; 6.31; 5.43; 6.01; 10.44 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Heartburn. |
3.11; 2.35; 4.30; 4.06; 5.46; 3.27 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Tired |
24.15; 18.62; 29.67; 40.92; 21.64; 27.24 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Irritable |
7.50; 5.71; 13.20; 13.01; 24.80; 24.56 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Energetic |
54.86; 67.01; 55.18; 21.03; 56.14; 58.11 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Relaxed |
72.66; 73.87; 67.77; 63.65; 63.87; 55.85 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Talkative |
54.17; 57.46; 50.61; 51.46; 51.43; 50.34 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Happy |
76.62; 79.70; 70.98; 71.34; 66.22; 64.04 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Nervous |
13.24; 10.26; 10.91; 8.46; 7.19; 8.22 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Sad |
3.95; 2.09; 6.77; 4.48; 5.67; 10.51 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Calm |
74.35; 76.52; 73.15; 69.23; 65.65; 61.15 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Depressed |
3.97; 2.87; 4.99; 5.55; 6.43; 6.85 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Drowsy |
16.63; 14.29; 24.25; 30.17; 17.14; 15.43 | — |
| SECONDARY Visual Analog Scale (VAS) Question: Anxious |
16.69; 15.62; 15.02; 12.65; 20.20; 17.38 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Negative Affect |
11.94; 11.43; 10.64; 10.57; 11.25; 11.03 | — |
| SECONDARY Positive and Negative Affect Schedule (PANAS) Positive Affect |
37.10; 37.23; 35.72; 36.11; 36.08; 36.55 | — |
| SECONDARY Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine |
71.45; 71.01; 74.87; 75.25 | — |
| SECONDARY Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine |
67.72; 67.84; 67.84; 64.72 | — |
| SECONDARY Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine |
26.25; 25.92; 25.39; 28.70 | — |
| SECONDARY Nicotine Effects Questionnaire (NEQ) Question: Head Rush |
30.58; 29.38; 40.23; 42.48 | — |
Eligibility Criteria
Inclusion Criteria
- Female and male smokers, aged 18 to 50 years;
- History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion);
- Not seeking treatment at the time of the study for nicotine dependence;
- Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm;
- Clean urine drug screen (marijuana is permissible);
- In good health as verified by medical history;
- For women, not pregnant as determined by pregnancy screening, nor breast feeding.
Exclusion Criteria
- History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder;
- Lifetime history of schizophrenia or other psychotic disorder;
- Lifetime substance dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview
- Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview
- Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
- Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Data sourced from ClinicalTrials.gov (NCT01954966) and the linked publication. 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.