NCT03075501

Brief Summary

The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

4.7 years

First QC Date

May 18, 2016

Results QC Date

November 27, 2020

Last Update Submit

April 28, 2021

Conditions

Substance-Related Disorders

Keywords

drug cues

Outcome Measures

Primary Outcomes (1)

  • Change in Time Spent in Drug-paired Room

    The amount of time spent in the two testing rooms is assessed during a 10min exploration test conducted at the orientation session (pre-test) and again at the testing session (post-test). Between the pre- and post-tests, participants complete 4 drug administration sessions; 2 with 20mg MA, 2 with 0mg MA. The Paired Group always receives 20mg MA in the room they spent the least time in at pre-test, and 0mg MA in the other room. The Unpaired Group receives 20mg MA and 0mg MA once in each room. The research question is whether the Paired Group spends significantly more time in the room paired with 20mg MA in comparison to the Unpaired Group. Thus, the outcome measure is the difference in time spent in the room paired with drug administration (i.e. the room that they spent the least time in at pre-test) between pre- and post-tests (i.e., post-test time spent - pre-test time spent) which is compared between the groups. NOTE: Time spent is NOT obtained during drug administration sessions.

    Measured through study completion (maximum 5 weeks).

Secondary Outcomes (1)

  • Subjective Drug Effects

    Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.

Study Arms (2)

Paired

ACTIVE COMPARATOR

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room.

Behavioral: PairedDrug: Stimulant or sedativeDrug: Placebo

Unpaired

OTHER

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms.

Drug: Stimulant or sedativeDrug: Placebo

Interventions

PairedBEHAVIORAL

Drug conditioning is assessed by pairing drug administration with a given context.

Also known as: Conditioned place preference
Paired
Stimulant or sedativeDRUG

CS+ for paired, CS0 for unpaired

PairedUnpaired
PlaceboDRUG

CS- for paired, CS0 for unpaired

PairedUnpaired

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • past use of stimulants
  • bmi 19-26
  • hormonal birth control for women

You may not qualify if:

  • current or recent (Past year) history of major axis I disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Central Nervous System StimulantsHypnotics and Sedatives

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesCentral Nervous System Depressants

Results Point of Contact

Title
Emma Childs
Organization
University of Illinois at Chicago
echilds@uic.edu
312-355-2726

Study Officials

  • Emma Childs, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2016

First Posted

March 9, 2017

Study Start

November 1, 2015

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

May 19, 2021

Results First Posted

May 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)