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The aim of the study is to extend our investigations of drug-associated conditioning with healthy volunteers. The investigators have recently completed a pilot study demonstrating that subjects show an increase in self-reported preference for a visual stimulus paired with stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts synergistically with rewards in the environment, such that this conditioning effect is facilitated by experiencing the drug in the presence of rewarding, or positive events, such as earning money. The investigators now aim to extend these findings by assessing not only self-reported preference, but also attentional and psychophysiological (electromyogram; EMG) responses to the drug-associated stimuli.
The study will consist of an orientation session following by 6 experimental study sessions. The first experimental session will consist of a "Pre-test", where baseline data regarding attentional, psychophysiological, and self-reported responses tovarious stimuli will be collected. The following 4 sessions will consist of a drug (sedative or stimulant) or placebo. During these sessions, subjects will play simple computer games, as well as complete questionnaires regarding mood and potential subjective drug effects. The subjects will then complete a "Test" session, where attentional, psychophysiological, and self-reported responses to the stimuli will be assessed, as in the first experimental session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paired, high reward | Experimental | All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. |
|
| Paired, low reward | Experimental | All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. |
|
| Paired no reward | Experimental | All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. |
|
| Unpaired, high reward | Experimental | All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. |
|
| Unpaired, low reward |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methamphetamine | Drug | : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire | The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. | End of study (time 0 and approximately 4 weeks later) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leah Mayo | Graduate Student | Study Director |
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Healthy volunteers aged 18-35 were recruited through posters, online and newspaper advertisement, and word-of mouth referrals throughout the community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paired, High Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) placebo: Placebo (sugar pill) |
| FG001 | Paired, Low Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| FG002 | Paired, no Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| FG003 | Unpaired, High Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| FG004 | Unpaired, Low Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy volunteers aged 18-35 with BMI between 19 and 26kg/m2, at least high school completed educated., resting bp less than 140/90, current alcohol consumption less than 4 drinks per day, less than 4 caffenated beverages per day. No major DSM IV disorder, no current psychoactive medication, no pregnancy
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| ID | Title | Description |
|---|---|---|
| BG000 | Paired, High Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire | The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | End of study (time 0 and approximately 4 weeks later) |
|
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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 | Paired, No Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harriet de Wit | University of Chicago | 773-702-3560 | dewitlab@yoda.bsd.uchicago.edu |
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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 |
|---|---|
| D008694 | Methamphetamine |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Experimental |
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions. |
|
|
| placebo | Drug | Placebo (sugar pill) |
|
|
| Paired, Low Reward |
All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| BG002 | Paired, no Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| BG003 | Unpaired, High Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| BG004 | Unpaired, Low Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Paired, Low Reward (Methamphetamine Sessions) | All subjects received methamphetamine (20 mg) on two conditioning sessions |
| OG002 | Paired no Reward (Methamphetamine Sessions) | All subjects received methamphetamine (20 mg) on two conditioning sessions |
| OG003 | Unpaired, High Reward (Methamphetamine Sessions) | All subjects received methamphetamine (20 mg) on two conditioning sessions |
| OG004 | Unpaired, Low Reward (Methamphetamine Sessions) | All subjects received methamphetamine (20 mg) on two conditioning sessions |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Paired, Low Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Paired, High Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Unpaired, Low Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Unpaired, High Reward | All participants will be administered methamphetamine (20mg) and placebo. methamphetamine: : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone. placebo: Placebo (sugar pill) | 0 | 7 | 0 | 7 | 0 | 7 |
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| Organic Chemicals |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |