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NCT01589055
IV Nicotine Induced Changes in Hormone Function, Mood States and Behavior
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 Withdrawn.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| Status | Withdrawn |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 | single |
| Primary purpose | other |
| Start date | 1 April 2005 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 December 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Intravenous Nicotine — 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.
-
Effects of nicotine on hormones and mood states
Time frame: From baseline to study completion (approximately 4 months for males and 8 months for females)
We are examining the effects of IV nicotine on serum nicotine levels, serum/plasma hormone levels and nicotine-induced changes in subjective statues, as measured by a visual analog scale.
Sponsor's own description
Clinical studies are proposed to analyze the interactions between nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies are designed to examine the contribution of gender and menstrual cycle phase. It is hypothesized that analysis of nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing understanding of the neurobiology of nicotine reinforcement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01589055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07001930 — Effects of Cannabidiol on Stress and Nicotine Withdrawal · Phase 1 · recruiting
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Other Mclean Hospital trials
Trials by the same sponsor.
- NCT07519759 — Recovery Inspired Support Engagement (RISE) Pilot · NA · not yet recruiting
- NCT07503093 — Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis · NA · not yet recruiting
- NCT07503067 — Identifying Substance Use Consequences · recruiting
- 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 NCT01589055 (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/NCT01589055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing