Nicotine Virtual Reality Conditioned Place Preference

NCT ID: NCT06259630

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-03

Study Completion Date

2018-06-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nicotine Addiction Nicotine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo followed by Nicotine Arm

Participant receives placebo on day 1 and nicotine on day 2.

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Participant receives oral dose of nicotine

Placebo oral capsule

Intervention Type DRUG

Participant receives oral dose of placebo

Nicotine followed by Placebo Arm

Participant receives nicotine on day 1 and placebo on day 2.

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Participant receives oral dose of nicotine

Placebo oral capsule

Intervention Type DRUG

Participant receives oral dose of placebo

Placebo followed by Placebo Arm

Participant receives placebo on day 1 and day 2.

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Participant receives oral dose of placebo

Interventions

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Nicotine

Participant receives oral dose of nicotine

Intervention Type DRUG

Placebo oral capsule

Participant receives oral dose of placebo

Intervention Type DRUG

Eligibility Criteria

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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).


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago Medical Center - Human Behavioral Pharmacology Lab

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16565827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24657735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12202970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19111278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24935353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24317443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15734728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23487003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23089383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18440720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9871940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21480731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11260807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26187342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17019569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4762224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25811710 (View on PubMed)

Other Identifiers

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IRB15-1337

Identifier Type: -

Identifier Source: org_study_id

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