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NCT01034020
Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers
Phase 1 trial testing Nicotine in Substance Related Disorder in 100 participants. Completed in 3 November 2009.
3 November 2009
Quick facts
| Lead sponsor | National Institute on Drug Abuse (NIDA) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 14 February 2006 |
| Primary completion | 3 November 2009 |
| Estimated completion | 3 November 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Nicotine (NICOTINE) — full drug profile →
Conditions studied
- Substance Related Disorder — all drugs for Substance Related Disorder →
- Nicotine Dependence — all drugs for Nicotine Dependence →
Sponsor
National Institute on Drug Abuse (NIDA)
Who can join
Adults 18 to 50, any sex, with Substance Related Disorder or Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: \- Many cigarette smokers claim that smoking helps them stay alert and improves their concentration, and have reported problems in attention and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain's ability to pay attention. Knowing which aspects of attention are affected by nicotine may help produce new medications and therapies to help people successfully stop smoking. Objectives: * To investigate the dose-related effects of nicotine on the ability to pay attention in smokers and nonsmokers. * To compare the effects of nicotine in smokers and nonsmokers. Eligibility: \- Individuals between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers. Design: * The study will consist of one training session and three testing sessions. Each session will last about 2 hours. * The training session will introduce participants to the study tests and evaluate their tolerance of the two levels of nicotine nasal spray used in the study. Smokers will receive the higher dose of nicotine to introduce them to the effects of the spray. Nonsmokers will be given first the lower dose of the spray, followed by higher dose at least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will not continue in the study. * At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine. * During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate mood, attention, and performance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01034020
- Europe PMC full search
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- ESMO Meeting Library
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Other National Institute on Drug Abuse (NIDA) trials
Trials by the same sponsor.
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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 NCT01034020 (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 National Institute on Drug Abuse (NIDA)
- Last refreshed: 2 July 2017
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/NCT01034020.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing