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Nicotine AddictionPhase 4NEVENCT06259630

Nicotine Virtual Reality Conditioned Place Preference

A Phase 4 study testing Nicotine in people with Nicotine Addiction and Nicotine Use Disorder, run by University of Chicago at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Nicotine Addiction, Nicotine Use Disorder
What is being tested?
Nicotine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
3 Nov 2015to 22 Jun 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Medical Center - Human Behavioral Pharmacology Lab

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Effect of Nicotine on Acquisition and Extinction of a Conditioned Place Preference in a Virtual Reality Environment

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.

Read the detailed 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.

Being tested
Nicotine, Placebo oral capsule
Keywords
Nicotine
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicotineDrug

    Participant receives oral dose of nicotine

  • Placebo oral capsuleDrug

    Participant receives oral dose of placebo

Study groups in NCT06259630
Study groupRoleWhat they receive
Placebo followed by Nicotine ArmExperimentalParticipant receives placebo on day 1 and nicotine on day 2.
Receives: Drug: Nicotine; Drug: Placebo oral capsule
Nicotine followed by Placebo ArmExperimentalParticipant receives nicotine on day 1 and placebo on day 2.
Receives: Drug: Nicotine; Drug: Placebo oral capsule
Placebo followed by Placebo ArmPlacebo comparatorParticipant receives placebo on day 1 and day 2.
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virtual Environment "Liking"

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

Secondary outcomes (1)

  1. Time spent in virtual environment

    Measured: Participants actively choose which environment to spend time in. The length of those virtual visits is measured and compared during the study sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start3 Nov 2015
  3. Primary completion22 Jun 2018
  4. Study completion22 Jun 2018

Why it stopped: Investigators no longer wanted to pursue this research topic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06259630
Sponsor's protocol ID
IRB15-1337
Acronym
NEVE
Status last verified
Feb 2024
First submitted
15 Feb 2017
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16565827

  • 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.

    PubMed 24657735

  • 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.

    PubMed 12202970

  • 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.

    PubMed 19111278

  • 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.

    PubMed 24935353

  • 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.

    PubMed 24317443

  • 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.

    PubMed 15734728

  • 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.

    PubMed 23487003

  • 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.

    PubMed 23089383

  • 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.

    PubMed 18440720

  • 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.

    PubMed 9871940

  • 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.

    PubMed 21480731

  • 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.

    PubMed 11260807

  • 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.

    PubMed 26187342

  • 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.

    PubMed 17019569

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicotine in people with Nicotine Addiction and Nicotine Use Disorder, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virtual Environment "Liking" (time frame: Participant rate on a visual analog scale how much they prefer one virtual environment over another). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06259630, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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