Substance Abuse
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGmethamphetamine
: 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.
DRUGplacebo
Placebo (sugar pill)
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI of 19-26kg/m, high school education, * fluency in English, * resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day.
Exclusion criteria
* current substance abuse or lifetime substance dependence, * regular medication, * history of cardiovascular illness, * current major Axis I DSM-IV disorder (APA, 2004), * mood disorder or psychotic symptoms within the past year. * Shift workers and pregnant or nursing mothers will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | End of study (time 0 and approximately 4 weeks later) | 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. |
Participant flow
Recruitment details
Healthy volunteers aged 18-35 were recruited through posters, online and newspaper advertisement, and word-of mouth referrals throughout the community.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 24 |
| 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) | 24 |
| 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) | 23 |
| 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) | 7 |
| 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) | 9 |
| Total | 87 |
Baseline characteristics
| Characteristic | Paired, High Reward | Paired, Low Reward | Paired, no Reward | Unpaired, Low Reward | Unpaired, High Reward | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 23 Participants | 9 Participants | 7 Participants | 87 Participants |
| Age, Continuous | 24.8 years STANDARD_DEVIATION 5 | 23.9 years STANDARD_DEVIATION 3.3 | 22.8 years STANDARD_DEVIATION 2.3 | 24.2 years STANDARD_DEVIATION 3.7 | 23.3 years STANDARD_DEVIATION 3 | 23.8 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 24 Participants | 24 Participants | 23 Participants | 9 Participants | 7 Participants | 87 Participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 13 Participants | 4 Participants | 5 Participants | 49 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 10 Participants | 5 Participants | 2 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 | 0 / 24 | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 0 / 23 | 0 / 24 | 0 / 24 | 0 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 | 0 / 24 | 0 / 9 | 0 / 7 |
Outcome results
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.
Time frame: End of study (time 0 and approximately 4 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 50.39 units on a scale | Standard Deviation 3.29 |
| Paired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 68.85 units on a scale | Standard Deviation 3.32 |
| Paired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 42.04 units on a scale | Standard Deviation 3.79 |
| Paired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 65.11 units on a scale | Standard Deviation 3.98 |
| Paired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 45.25 units on a scale | Standard Deviation 3 |
| Paired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 62.44 units on a scale | Standard Deviation 3.55 |
| Paired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 64.25 units on a scale | Standard Deviation 3.1 |
| Paired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 41.04 units on a scale | Standard Deviation 3.55 |
| Paired no Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 61.55 units on a scale | Standard Deviation 3.44 |
| Paired no Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 60.55 units on a scale | Standard Deviation 3 |
| Paired no Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 38.88 units on a scale | Standard Deviation 3.45 |
| Paired no Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 41.22 units on a scale | Standard Deviation 2.5 |
| Unpaired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 48.55 units on a scale | Standard Deviation 2.6 |
| Unpaired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 61.55 units on a scale | Standard Deviation 3.5 |
| Unpaired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 60.55 units on a scale | Standard Deviation 3.42 |
| Unpaired, High Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 39.55 units on a scale | Standard Deviation 3.45 |
| Unpaired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 59.5 units on a scale | Standard Deviation 3.1 |
| Unpaired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 38.0 units on a scale | Standard Deviation 3.42 |
| Unpaired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 60.2 units on a scale | Standard Deviation 3.4 |
| Unpaired, Low Reward (Methamphetamine Sessions) | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 42.22 units on a scale | Standard Deviation 2.5 |