Nicotine Virtual Reality Conditioned Place Preference

NCT06259630 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB15-1337
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Addiction; Nicotine Use Disorder

Keywords

Nicotine

Outcome Measures

Primary Outcomes (1)

• Virtual Environment "Liking"

  Participant rate on a visual analog scale how much they prefer one virtual environment over another

Secondary Outcomes (1)

• 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

Study Arms (3)

Placebo followed by Nicotine Arm

EXPERIMENTAL

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

Drug: Nicotine; Drug: Placebo oral capsule

Nicotine followed by Placebo Arm

EXPERIMENTAL

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

Drug: Nicotine; Drug: Placebo oral capsule

Placebo followed by Placebo Arm

PLACEBO COMPARATOR

Participant receives placebo on day 1 and day 2.

Drug: Placebo oral capsule

Interventions

Nicotine DRUG

Participant receives oral dose of nicotine

Nicotine followed by Placebo Arm; Placebo followed by Nicotine Arm

Placebo oral capsule DRUG

Participant receives oral dose of placebo

Nicotine followed by Placebo Arm; Placebo followed by Nicotine Arm; Placebo followed by Placebo Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have at least a high school education and be in good physical and mental health.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center - Human Behavioral Pharmacology Lab

Chicago, Illinois, 60637, United States

Location

Related Publications (17)

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  PMID: 16565827 BACKGROUND

• 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.

  PMID: 24657735 BACKGROUND

• 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.

  PMID: 12202970 BACKGROUND

• 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.

  PMID: 19111278 BACKGROUND

• 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.

  PMID: 24935353 BACKGROUND

• 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.

  PMID: 24317443 BACKGROUND

• 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.

  PMID: 15734728 BACKGROUND

• 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.

  PMID: 23487003 BACKGROUND

• 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.

  PMID: 23089383 BACKGROUND

• 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.

  PMID: 18440720 BACKGROUND

• 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.

  PMID: 9871940 BACKGROUND

• 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.

  PMID: 21480731 BACKGROUND

• 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.

  PMID: 11260807 BACKGROUND

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  PMID: 26187342 BACKGROUND

• 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.

  PMID: 17019569 BACKGROUND

• 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.

  PMID: 4762224 BACKGROUND

• 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.

  PMID: 25811710 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 14, 2024
• Study Start: November 3, 2015
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)