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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06259630
Other study ID # IRB15-1337
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date November 3, 2015
Est. completion date June 22, 2018

Study information

Verified date February 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this between-subjects, placebo controlled, double-blind study, the investigators will examine the effects of low oral doses of nicotine on the learning and extinction of a conditioned place preference acquired in a virtual reality environment by healthy human subjects. Physiological and subjective responses to the drug will also be monitored.


Description:

External cues and contexts contribute to the development of smoking and the use of other drugs, and drugs themselves can alter the value of conditioned cues. Interestingly, nicotine increases the acquisition of new learning, and has been considered as a "cognitive enhancer". Nicotine also prolongs responding when responding is no longer rewarded, during extinction. Although many studies have examined the effects of drugs on learning (acquisition) and unlearning (extinction) in laboratory animals, few have investigated drug effects on learning in humans. Recently, novel procedures have been developed to study conditioning in humans, pairing initially neutral places with food, money or drugs. The investigators will use one of these procedures, a virtual place conditioning procedure, to study how nicotine affects the acquisition and extinction of conditioned behaviors in humans.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 22, 2018
Est. primary completion date June 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Subjects must have at least a high school education and be in good physical and mental health. Exclusion Criteria: - Individuals with current medical conditions, and/or a history of serious medical problems (e.g., cardiac, kidney, liver, and neurological). Additional Exclusion Criteria include: - regular medication, - pregnancy, - color blindness, - left-handedness, - consumption of 5 or more cigarettes per day, - English non-fluency and current DSM-IV Axis 1 diagnosis excluding nicotine dependence.

Study Design


Intervention

Drug:
Nicotine
Participant receives oral dose of nicotine
Placebo oral capsule
Participant receives oral dose of placebo

Locations

Country Name City State
United States University of Chicago Medical Center - Human Behavioral Pharmacology Lab Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (17)

Acheson A, Mahler SV, Chi H, de Wit H. Differential effects of nicotine on alcohol consumption in men and women. Psychopharmacology (Berl). 2006 May;186(1):54-63. doi: 10.1007/s00213-006-0338-y. Epub 2006 Mar 25. — View Citation

Adam KC, Mance I, Fukuda K, Vogel EK. The contribution of attentional lapses to individual differences in visual working memory capacity. J Cogn Neurosci. 2015 Aug;27(8):1601-16. doi: 10.1162/jocn_a_00811. Epub 2015 Mar 26. — View Citation

Astur RS, Carew AW, Deaton BE. Conditioned place preferences in humans using virtual reality. Behav Brain Res. 2014 Jul 1;267:173-7. doi: 10.1016/j.bbr.2014.03.018. Epub 2014 Mar 20. — View Citation

Caggiula AR, Donny EC, White AR, Chaudhri N, Booth S, Gharib MA, Hoffman A, Perkins KA, Sved AF. Environmental stimuli promote the acquisition of nicotine self-administration in rats. Psychopharmacology (Berl). 2002 Sep;163(2):230-7. doi: 10.1007/s00213-002-1156-5. Epub 2002 Jul 13. — View Citation

Chaudhri N, Caggiula AR, Donny EC, Booth S, Gharib M, Craven L, Palmatier MI, Liu X, Sved AF. Operant responding for conditioned and unconditioned reinforcers in rats is differentially enhanced by the primary reinforcing and reinforcement-enhancing effects of nicotine. Psychopharmacology (Berl). 2006 Nov;189(1):27-36. doi: 10.1007/s00213-006-0522-0. Epub 2006 Sep 22. — View Citation

Childs E, de Wit H. Amphetamine-induced place preference in humans. Biol Psychiatry. 2009 May 15;65(10):900-4. doi: 10.1016/j.biopsych.2008.11.016. Epub 2008 Dec 25. — View Citation

Everitt BJ. Neural and psychological mechanisms underlying compulsive drug seeking habits and drug memories--indications for novel treatments of addiction. Eur J Neurosci. 2014 Jul;40(1):2163-82. doi: 10.1111/ejn.12644. Epub 2014 Jun 17. — View Citation

Folstein MF, Luria R. Reliability, validity, and clinical application of the Visual Analogue Mood Scale. Psychol Med. 1973 Nov;3(4):479-86. doi: 10.1017/s0033291700054283. No abstract available. — View Citation

Fond G, Micoulaud-Franchi JA, Brunel L, Macgregor A, Miot S, Lopez R, Richieri R, Abbar M, Lancon C, Repantis D. Innovative mechanisms of action for pharmaceutical cognitive enhancement: A systematic review. Psychiatry Res. 2015 Sep 30;229(1-2):12-20. doi: 10.1016/j.psychres.2015.07.006. Epub 2015 Jul 8. — View Citation

Gould TJ, Collins AC, Wehner JM. Nicotine enhances latent inhibition and ameliorates ethanol-induced deficits in latent inhibition. Nicotine Tob Res. 2001 Feb;3(1):17-24. doi: 10.1080/14622200020032060. — View Citation

Guy EG, Fletcher PJ. The effects of nicotine exposure during Pavlovian conditioning in rats on several measures of incentive motivation for a conditioned stimulus paired with water. Psychopharmacology (Berl). 2014 Jun;231(11):2261-71. doi: 10.1007/s00213-013-3375-3. Epub 2013 Dec 7. — View Citation

Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3. — View Citation

Hutton-Bedbrook K, McNally GP. The promises and pitfalls of retrieval-extinction procedures in preventing relapse to drug seeking. Front Psychiatry. 2013 Mar 12;4:14. doi: 10.3389/fpsyt.2013.00014. eCollection 2013. — View Citation

Molet M, Billiet G, Bardo MT. Conditioned place preference and aversion for music in a virtual reality environment. Behav Processes. 2013 Jan;92:31-5. doi: 10.1016/j.beproc.2012.10.001. Epub 2012 Oct 23. — View Citation

Tian S, Gao J, Han L, Fu J, Li C, Li Z. Prior chronic nicotine impairs cued fear extinction but enhances contextual fear conditioning in rats. Neuroscience. 2008 Jun 2;153(4):935-43. doi: 10.1016/j.neuroscience.2008.03.005. Epub 2008 Mar 8. — View Citation

Tzschentke TM. Measuring reward with the conditioned place preference paradigm: a comprehensive review of drug effects, recent progress and new issues. Prog Neurobiol. 1998 Dec;56(6):613-72. doi: 10.1016/s0301-0082(98)00060-4. — View Citation

Wignall ND, de Wit H. Effects of nicotine on attention and inhibitory control in healthy nonsmokers. Exp Clin Psychopharmacol. 2011 Jun;19(3):183-91. doi: 10.1037/a0023292. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Virtual Environment "Liking" Participant rate on a visual analog scale how much they prefer one virtual environment over another
Secondary Time spent in virtual environment Participants actively choose which environment to spend time in. The length of those virtual visits is measured and compared during the study sessions
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