Nicotine Virtual Reality Conditioned Place Preference

Phase 4

Withdrawn

• Conditions: Nicotine Use Disorder; Nicotine Addiction
• Interventions: Drug: Nicotine; Drug: Placebo oral capsule

• Registration Number: NCT06259630
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study Start: 2015-11-03
• Study First Submitted: 2017-02-15
• Primary Completion: 2018-06-22
• Study Completion: 2018-06-22
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo followed by Nicotine Arm	Placebo oral capsule	Participant receives placebo on day 1 and nicotine on day 2.
Nicotine followed by Placebo Arm	Placebo oral capsule	Participant receives nicotine on day 1 and placebo on day 2.
Placebo followed by Placebo Arm	Placebo oral capsule	Participant receives placebo on day 1 and day 2.
Placebo followed by Nicotine Arm	Nicotine	Participant receives placebo on day 1 and nicotine on day 2.
Nicotine followed by Placebo Arm	Nicotine	Participant receives nicotine on day 1 and placebo on day 2.

Primary Outcome Measures

Name	Time	Method
Virtual Environment "Liking"	Participant rate on a visual analog scale how much they prefer one virtual environment over another

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Chicago Medical Center - Human Behavioral Pharmacology Lab; 🇺🇸 Chicago, Illinois, United States