NCT01722006

Brief Summary

Classical conditioning is widely used to study motivational properties of addictive drugs in animals, but has rarely been used in humans. Here, we are establishing a procedure suitable for studying the neurobiology and individual determinants of classical conditioning in humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine or placebo in the presence of distinctive environmental cues under paired or unpaired conditions. During each session, subjects perform tasks known to activate the ventral striatum in fMRI studies. The tasks are performed in the presence of a distinctive context, consisting of a screen background image of a beach or of mountains, accompanied by corresponding sounds. Separate groups of subjects carry out the tasks under high or low reward conditions. Within each of the two reward conditions, one group (paired), receives methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts, while the other (unpaired) receives drug or placebo unrelated to context. A fifth group (paired) perform the tasks with contextual cues but in the absence of monetary incentives. Before and after conditioning, participants carry out a series of forced choice tasks, and change of preference over time was analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
Last Updated

September 5, 2013

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

October 29, 2012

Last Update Submit

September 4, 2013

Conditions

Keywords

methamphetaminesubjectiveconditioningpreference

Outcome Measures

Primary Outcomes (1)

  • Preference for paired stimulus

    Subjects rate their preference for several pairs of stimuli before and after conditioning pairings. The stimuli are presented on a computer screen in the pre and post preference tests, and the change in preference after the conditioning trials is the primary outcome measure.

    2-3 weeks

Secondary Outcomes (1)

  • Subjective responses to methamphetamine

    2-3 weeks

Study Arms (1)

Pairing group

Paired, high reward, oral methamphetamine (20 mg) vs placebo Paired, low reward, oral methamphetamine (20 mg) vs placebo Paired, no reward, oral methamphetamine (20 mg) vs placebo Unpaired, oral methamphetamine (20 mg) vs placebo

Behavioral: Pairing condition

Interventions

Pairing group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy adults

You may qualify if:

  • , good healthy, normal weight, high school education, normal electrocardiogram, no psychiatric disorders,

You may not qualify if:

  • current medications, night shift work, abnormal electrocardiogram, medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Harriet de Wit, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 6, 2012

Study Start

December 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 5, 2013

Record last verified: 2012-11

Locations