Effect of Affective Content on Drug Induced Amnesia of Episodic Memory

NCT00142493 | Completed Phase 1

• 1 other identifier: 04-087
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to understand how some of the drugs commonly used in anesthesia impair memory. We are particularly interested in whether the emotion associated with a memory influences how well these drugs are able to block memory. We are studying four commonly used drugs-propofol, thiopental, midazolam, and dexmedetomidine, all of which may have slightly differing effects. We will also study an inactive substance, called a placebo, that should have no effect. The results of this study will provide information that will be useful in understanding how memory works, how these drugs affect memory, and possibly why some people don't have their memory blocked as easily as others.

Conditions

Memory Losses; Amnesia-Memory Loss

Keywords

Episodic Memory; Amnesia; Amnesia, Temporary

Outcome Measures

Primary Outcomes (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

  over a two day period

Secondary Outcomes (1)

• To study whether the subliminal ('consciously imperceptible') presentation of emotional words can influence memory for visual stimuli shown immediately after the subliminal presentation

  over a two day period

Study Arms (5)

1

EXPERIMENTAL

Drug: Propofol

2

EXPERIMENTAL

Drug: Thiopental Sodium

3

EXPERIMENTAL

Drug: Dexmedetomidine Hydrochloride

4

EXPERIMENTAL

Drug: Midazolam Hydrochloride

5

PLACEBO COMPARATOR

Drug: placebo

Interventions

Propofol DRUG

1.2ug/ml

1

Thiopental Sodium DRUG

2.0ug/ml

2

Dexmedetomidine Hydrochloride DRUG

0.5ng/ml

3

Midazolam Hydrochloride DRUG

60ng/ml

4

placebo DRUG

intralipid, saline, saline with multi-Vit solution

5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Memory Disorders; Amnesia

Interventions

Propofol; Thiopental; Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kane O. Pryor, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (1)