Effect of Affective Content on Drug Induced Amnesia of Episodic Memory
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ClinicalTrials.gov Identifier: NCT00142493 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : December 24, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Memory Losses Amnesia-Memory Loss | Drug: Propofol Drug: Thiopental Sodium Drug: Dexmedetomidine Hydrochloride Drug: Midazolam Hydrochloride Drug: placebo | Phase 1 |
The protocol "Effect of Affective Content on Drug Induced Amnesia of Episodic Memory" investigates the relationship between the ability of affective ('emotional') content to modulate the formation of episodic memory, and the memory impairment ('amnestic') effects of several common intravenous anesthetic drugs. Because memory modulation by affective content appears to be a distinct memory process, the underlying question is whether drugs that impair memory via different mechanisms will have differing effects on memory modulation. Specifically, the objectives are: (1) To study the influence of three GABAergic agents (thiopental, propofol, and midazolam) and one α2-adrenergic agent (dexmedetomidine) on the ability of affective content to modulate the strength of episodic memory; and (2) To study whether the subliminal ('consciously imperceptible') presentation of emotional words can influence memory for visual stimuli shown immediately after the subliminal presentation.
A maximum of eighty volunteers will receive sub-anesthetic doses of one of the four study drugs, or placebo, while performing a visual continuous recognition task ('CRT') of pictures with randomly varying affective load. Drug effect on affective modulation of working and early long-term memory behavior will be examined by analyzing which images are and are not recognized during the CRT. Drug effect on affective modulation of later long-term memory will be examined by analyzing which images are recognized several hours after presentation.
In a second experiment, emotive and non-emotive words are subliminally presented immediately before the presentation of a 'bland' picture. The ability of the subliminally presented word to influence memory will be examined by analyzing which bland images are recognized several hours later.
Three hypotheses are tested:
The memory impairment effected by GABAergic drugs will be stronger for memory of emotively positive images than for memory of emotively negative images
The memory impairment effected by dexmedetomidine will be similar for memory of emotively positive and negative images
Recognition memory for neutral, non-arousing images will be greater if the image is immediately preceded by the subliminal presentation of an emotively arousing word than if it is preceded by an emotively non-arousing word
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Affective Content on Drug Induced Amnesia of Episodic Memory |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Propofol
1.2ug/ml |
Experimental: 2 |
Drug: Thiopental Sodium
2.0ug/ml |
Experimental: 3 |
Drug: Dexmedetomidine Hydrochloride
0.5ng/ml |
Experimental: 4 |
Drug: Midazolam Hydrochloride
60ng/ml |
Placebo Comparator: 5 |
Drug: placebo
intralipid, saline, saline with multi-Vit solution |
- To study the influence of three GABAergic agents (thiopental, propofol, and midazolam) and one α2-adrenergic agent (dexmedetomidine) on the ability of affective content to modulate the strength of episodic memory [ Time Frame: over a two day period ]
- To study whether the subliminal ('consciously imperceptible') presentation of emotional words can influence memory for visual stimuli shown immediately after the subliminal presentation [ Time Frame: over a two day period ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy normal volunteers, age 18 to 50 years *,who show no evidence of neurologic deficit on questionnaire and physical examination.
- Females must be non-pregnant as demonstrated using a serum pregnancy test.
- Right hand dominant.
- High school education or above.
- English as native language or equivalent degree of fluency. *Age group selected based on pharmacokinetic models for drug infusion, and norms for standardized memory tests.
Exclusion Criteria:
- Any evidence of neurologic deficit including seizures, severe head trauma resulting in unconsciousness, or any previously abnormal study of CNS - (e.g. MRI, EEG, etc.)
- Any deficit in auditory or visual ability.
- Any history of hypertension (resting BP >150 systolic, >100 diastolic) or taking anti- hypertensive medication or cardiovascular disease.
- Significant pulmonary, renal, gastrointestinal, or endocrine metabolic disease which in the opinion of the investigator would complicate the goals of this study.
- Allergy to propofol or eggs.
- History of acute intermittent porphyria in subject or subject's blood relatives.
- History of substance abuse
- Currently taking centrally acting medications (e,g, benzodiazepines or anti depressants)
- Subjects whose body weight relative to their height exceeds accepted criteria for defining obesity in the general population (Body Mass Index > 30). Excess weight can affect the pharmacodynamics of the drug in the body.
- Anyone who, in the opinion of the investigators, would be unwilling or unable to tolerate the procedures and/or comply with the task instructions.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142493
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Kane O. Pryor, M.D. | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00142493 |
Other Study ID Numbers: |
04-087 |
First Posted: | September 2, 2005 Key Record Dates |
Last Update Posted: | December 24, 2015 |
Last Verified: | December 2015 |
Episodic Memory Amnesia Amnesia, Temporary |
Memory Disorders Amnesia Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders Midazolam Dexmedetomidine Thiopental Propofol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous |
Anesthetics, General Anesthetics Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents |