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NCT01589068
Effects of Progesterone on IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones and Subjective Ratings of Stimulant Drugs
NA trial testing Intravenous Nicotine in Nicotine Dependence. Withdrawn.
1 December 2015
Quick facts
| Lead sponsor | Mclean Hospital |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Start date | 1 January 2007 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 December 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Intravenous Nicotine — full drug profile →
- Progesterone (Progesterone plus HCG) — full drug profile →
Conditions studied
- Nicotine Dependence — all drugs for Nicotine Dependence →
Sponsor
Mclean Hospital
Who can join
Adults 18 to 40, any sex, with Nicotine Dependence. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Effect of progesterone on IV nicotine, hormones and subjective ratings
Time frame: From baseline to study completion (approximately 8 months for males and 2 years for females)
We are examining the effects of progesterone on the acute effects of IV nicotine and BOLD signal active in areas of the brain with high levels of nicotine receptors. Correlational analyses between brain activation patterns, serum nicotine levels, serum/plasma hormone levels, and nicotine-induced changes in subjective statues, as measured by a visual analog scale, are being evaluated.
Sponsor's own description
The proposed clinical studies will analyze the interactions between progesterone, nicotine, fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and cardiovascular measures. It is hypothesized that the administration of progesterone at a dose that mimics luteal phase levels in normal cycling women will diminish the positive subjective effects of nicotine, as has been consistently observed for cocaine. This novel approach could have direct implications for facilitating smoking cessation treatment in women of reproductive age
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01589068
- Europe PMC full search
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- ESMO Meeting Library
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Other Mclean Hospital trials
Trials by the same sponsor.
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- NCT06816329 — Stress Dynamics and Familial Risk for Depression in Female Adolescents · NA · recruiting
- NCT06876129 — Pharmacologic Augmentation of TMS for Depression With D-serine · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01589068 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mclean Hospital
- Last refreshed: 15 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01589068.
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