- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075501
Interactions Between Drug Effects and Environments II
Drug Contextual Conditioning With in Humans: Causes and Consequences
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Paired
Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions.
Individuals receive drug in only one room.
|
Drug conditioning is assessed by pairing drug administration with a given context.
Other Names:
CS+ for paired, CS0 for unpaired
CS- for paired, CS0 for unpaired
|
OTHER: Unpaired
Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions.
Individuals receive drug in both rooms.
|
CS+ for paired, CS0 for unpaired
CS- for paired, CS0 for unpaired
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Time Spent in Drug-paired Room
Time Frame: Measured through study completion (maximum 5 weeks).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Drug Effects
Time Frame: Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.
|
Self-reported drug effects are measured using standardized questionnaires 30min before capsule administration (baseline) and at 30min intervals after capsule administration for 4h during each drug administration session. The peak change from baseline is calculated for each session and averaged across drug and placebo sessions. A net difference is calculated by subtracting the mean peak change from baseline during placebo sessions from the mean peak change from baseline during drug (20mg MA) sessions. Outcome measure: Subjective stimulation (i.e., feeling alert, aroused, energetic) is measured using the Amphetamine scale of the Addiction Research Center Inventory. Scores range from 0-11 with greater scores indicating greater 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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Emma Childs, PhD, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0075
- R21DA033488-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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