CAM: Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT02323048
• Collaborator: (none)
• Enrollment: 90
• Arms: 5
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Abuse	Drug: methamphetamine; Drug: placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans: Self-report, Behavioral, and Psychophysiological Measures.
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paired, high reward 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.	Drug: 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.; Other Names: desoxyn ; Drug: placebo; Placebo (sugar pill); Other Names: dextrose
Experimental: Paired, low reward 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.	Drug: 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.; Other Names: desoxyn ; Drug: placebo; Placebo (sugar pill); Other Names: dextrose
Experimental: Paired no reward 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.	Drug: 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.; Other Names: desoxyn ; Drug: placebo; Placebo (sugar pill); Other Names: dextrose
Experimental: Unpaired, high reward 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.	Drug: 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.; Other Names: desoxyn ; Drug: placebo; Placebo (sugar pill); Other Names: dextrose
Experimental: Unpaired, low reward 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.	Drug: 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.; Other Names: desoxyn ; Drug: placebo; Placebo (sugar pill); Other Names: dextrose

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Chicago

Investigators

• Study Director: Leah Mayo, Graduate Student

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02323048
• Other Study ID Numbers: 12-2047
• First Posted: Dec 23, 2014
• Last Update Posted: Jul 26, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Substance-Related Disorders; Methamphetamine

Study Results

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.

Arm/Group Title	Paired, High Reward	Paired, Low Reward	Paired, no Reward	Unpaired, High Reward	Unpaired, Low Reward
Arm/Group Description	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)	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)	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)	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)	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)
Period Title: Overall Study
STARTED	25	26	23	7	9
COMPLETED	24	24	23	7	9
NOT COMPLETED	1	2	0	0	0

Baseline Characteristics

Arm/Group Title	Paired, High Reward	Paired, Low Reward	Paired, no Reward	Unpaired, High Reward	Unpaired, Low Reward	Total
Arm/Group Description	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)	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)	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)	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)	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)	Total of all reporting groups
Overall Participants	24	24	23	7	9	87
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	24 100%	23 100%	7 100%	9 100%	87 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.8 (5.0)	23.9 (3.3)	22.8 (2.3)	23.3 (3.0)	24.2 (3.7)	23.8 (3.7)
Sex: Female, Male (Count of Participants)
Female	12 50%	15 62.5%	13 56.5%	5 71.4%	4 44.4%	49 56.3%
Male	12 50%	9 37.5%	10 43.5%	2 28.6%	5 55.6%	38 43.7%
Region of Enrollment (Count of Participants)
United States	24 100%	24 100%	23 100%	7 100%	9 100%	87 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paired, High Reward (Methamphetamine Sessions)	Paired, Low Reward (Methamphetamine Sessions)	Paired no Reward (Methamphetamine Sessions)	Unpaired, High Reward (Methamphetamine Sessions)	Unpaired, Low Reward (Methamphetamine Sessions)
Arm/Group Description	All subjects received methamphetamine (20 mg) on two conditioning sessions	All subjects received methamphetamine (20 mg) on two conditioning sessions	All subjects received methamphetamine (20 mg) on two conditioning sessions	All subjects received methamphetamine (20 mg) on two conditioning sessions	All subjects received methamphetamine (20 mg) on two conditioning sessions
Measure Participants	24	24	23	7	9
Feel Drug	50.39 (3.29)	45.25 (3.0)	41.22 (2.5)	48.55 (2.6)	42.22 (2.5)
Like Drug	68.85 (3.32)	64.25 (3.10)	60.55 (3.0)	61.55 (3.5)	60.2 (3.4)
Feel High	42.04 (3.79)	41.04 (3.55)	38.88 (3.45)	39.55 (3.45)	38.0 (3.42)
Want More	65.11 (3.98)	62.44 (3.55)	61.55 (3.44)	60.55 (3.42)	59.5 (3.10)

Adverse Events

Arm/Group Title	Paired, No Reward		Paired, Low Reward		Paired, High Reward		Unpaired, Low Reward		Unpaired, High Reward
Arm/Group Description	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)		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)		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)		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)		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)
All Cause Mortality
	Paired, No Reward		Paired, Low Reward		Paired, High Reward		Unpaired, Low Reward		Unpaired, High Reward
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)		0/24 (0%)		0/9 (0%)		0/7 (0%)
Serious Adverse Events
	Paired, No Reward		Paired, Low Reward		Paired, High Reward		Unpaired, Low Reward		Unpaired, High Reward
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)		0/24 (0%)		0/9 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Paired, No Reward		Paired, Low Reward		Paired, High Reward		Unpaired, Low Reward		Unpaired, High Reward
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)		0/24 (0%)		0/9 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.