Nicotine Virtual Reality Conditioned Place Preference (NEVE)

February 6, 2024 updated by: University of Chicago

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center - Human Behavioral Pharmacology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo followed by Nicotine Arm
Participant receives placebo on day 1 and nicotine on day 2.
Drug: Nicotine
Participant receives oral dose of nicotine
Drug: Placebo oral capsule
Participant receives oral dose of placebo
Experimental: Nicotine followed by Placebo Arm
Participant receives nicotine on day 1 and placebo on day 2.
Drug: Nicotine
Participant receives oral dose of nicotine
Drug: Placebo oral capsule
Participant receives oral dose of placebo
Placebo Comparator: Placebo followed by Placebo Arm
Participant receives placebo on day 1 and day 2.
Drug: Placebo oral capsule
Participant receives oral dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Virtual Environment "Liking"
Time Frame: Participant rate on a visual analog scale how much they prefer one virtual environment over another
Participant rate on a visual analog scale how much they prefer one virtual environment over another

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2015

Primary Completion (Actual)

June 22, 2018

Study Completion (Actual)

June 22, 2018

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-1337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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