Interactions Between Drug Effects and Environments II

NCT ID: NCT03075501

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-07-31

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.

Detailed Description

Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.

Conditions

Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Paired

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

Group Type: ACTIVE_COMPARATOR

Paired

Intervention Type: BEHAVIORAL

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

Stimulant or sedative

Intervention Type: DRUG

CS+ for paired, CS0 for unpaired

Placebo

Intervention Type: DRUG

CS- for paired, CS0 for unpaired

Unpaired

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

Group Type: OTHER

Stimulant or sedative

Intervention Type: DRUG

CS+ for paired, CS0 for unpaired

Placebo

Intervention Type: DRUG

CS- for paired, CS0 for unpaired

Interventions

Paired

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

Intervention Type: BEHAVIORAL

Stimulant or sedative

CS+ for paired, CS0 for unpaired

Intervention Type: DRUG

Placebo

CS- for paired, CS0 for unpaired

Intervention Type: DRUG

Other Intervention Names

Conditioned place preference

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Emma Childs

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma Childs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R21DA033488-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0075

Identifier Type: -

Identifier Source: org_study_id