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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA033488-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Unpaired | Other | Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paired | Behavioral | Drug conditioning is assessed by pairing drug administration with a given context. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Drug Effects | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Childs, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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Participants underwent screening procedures to exclude participants who did not meet the study eligibility criteria.
Participants (N=133) were enrolled in the study between November 2015 and May 2018. All procedures were completed at the Human Addiction Pharmacology Laboratory at the University of Illinois at Chicago.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paired | Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. Paired: Drug conditioning is assessed by pairing drug administration with a given context. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired |
| FG001 | Unpaired | Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paired | Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room. Paired: Drug conditioning is assessed by pairing drug administration with a given context. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Video recordings of the exploration tests (used to calculate time spent) were unavailable (corrupted) for at least one test (pre- or post-) for 3 Paired participants and 2 Unpaired participants. Thus, the participant numbers for this analysis are reduced in comparison to the total number of participants who completed the study. | Posted | Mean | Standard Deviation | seconds | Measured through study completion (maximum 5 weeks). |
Up to 5 weeks
Participants reported adverse effects during and after sessions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20mg Methamphetamine | Participants completed two drug administration sessions with 20mg methamphetamine. Self-reported side effects: At 30min intervals following drug administration (for 4h), they reported any side effects on a paper and pencil form. Drug side effects (Blurred vision, Dry mouth, Headache, Nausea, Heart racing, Shortness of breath, Dizziness/faintness, Restlessness, Chest discomfort, Shakiness or trembling (legs, arms, hands, feet), Pain or numbness in fingers or toes, Anxiety/tension) were each associated with a 100mm visual analogue scale anchored at the left hand side with "None" and at the right hand side with "Extreme". Participants placed a vertical line bisecting the scale that corresponded with how they were feeling at that time. Scores ranged from 0-100, with higher scores indicating more severe side effects. Cardiovascular Measures: Heart rate (bpm) and blood pressure mmHg) were monitored using a monitor 30min before drug administration (baseline) and at 30min intervals (for 4h) following drug administration. Serious adverse events were defined as any side effects reported in the "severe-extreme" range (i.e., >60) or any occasion when the study physician was consulted about high cardiovascular measures. Serious adverse events are reported for all participants who completed the study (N=109). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High heart rate and blood pressure | Cardiac disorders | Systematic Assessment | The physician was consulted on one occasion regarding high heart rate and blood pressure values in a participant after receiving 20mg MA. The participant reported no additional adverse effects and after resting, heart rate and blood pressure reduced. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emma Childs | University of Illinois at Chicago | 312-355-2726 | echilds@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 4, 2018 | Nov 23, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000697 | Central Nervous System Stimulants |
| D006993 | Hypnotics and Sedatives |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
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| Stimulant or sedative | Drug | CS+ for paired, CS0 for unpaired |
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| Placebo | Drug | CS- for paired, CS0 for unpaired |
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| Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session. |
| BG001 |
| Unpaired |
Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms. Stimulant or sedative: CS+ for paired, CS0 for unpaired Placebo: CS- for paired, CS0 for unpaired |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Subjective Drug Effects | 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. | Data was analyzed only for participants who had complete data for the primary outcome (time spent). | Posted | Mean | Standard Deviation | units on a scale | Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session. |
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| 0 |
| 109 |
| 11 |
| 109 |
| 0 |
| 109 |
| EG001 | 0mg Methamphetamine (Placebo) | Participants completed two drug administration sessions with 20mg methamphetamine. Self-reported side effects: At 30min intervals following drug administration (for 4h), they reported any side effects on a paper and pencil form. Drug side effects (Blurred vision, Dry mouth, Headache, Nausea, Heart racing, Shortness of breath, Dizziness/faintness, Restlessness, Chest discomfort, Shakiness or trembling (legs, arms, hands, feet), Pain or numbness in fingers or toes, Anxiety/tension) were each associated with a 100mm visual analogue scale anchored at the left hand side with "None" and at the right hand side with "Extreme". Participants placed a vertical line bisecting the scale that corresponded with how they were feeling at that time. Scores ranged from 0-100, with higher scores indicating more severe side effects. Cardiovascular Measures: Heart rate (bpm) and blood pressure mmHg) were monitored using a monitor 30min before drug administration (baseline) and at 30min intervals (for 4h) following drug administration. Serious adverse events were defined as any side effects reported in the "severe-extreme" range (i.e., >60) or any occasion when the study physician was consulted about high cardiovascular measures. Serious adverse events are reported for all participants who completed the study (N=109). | 0 | 109 | 2 | 109 | 0 | 109 |
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| Dry mouth | Nervous system disorders | Systematic Assessment |
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| Shakiness/Trembling | Nervous system disorders | Systematic Assessment |
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| Heart racing | Cardiac disorders | Systematic Assessment |
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| Dizziness/faintness | Nervous system disorders | Systematic Assessment |
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| D045506 | Therapeutic Uses |
| D002492 | Central Nervous System Depressants |