Memory LossesPhase 1NCT00142493
Effect of Affective Content on Drug Induced Amnesia of Episodic Memory
A Phase 1 study testing Propofol, Thiopental Sodium and Dexmedetomidine Hydrochloride in people with Memory Losses and Amnesia-Memory Loss, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Losses, Amnesia-Memory Loss
- What is being tested?
- Propofol, Thiopental Sodium and Dexmedetomidine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
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.
Read the detailed description
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
- Conditions
- Memory Losses, Amnesia-Memory Loss
- Being tested
- Propofol, Thiopental Sodium, Dexmedetomidine Hydrochloride, Midazolam Hydrochloride, placebo
- Keywords
- Episodic Memory, Amnesia, Amnesia, Temporary
- Medical subject headings
- Memory Disorders, Amnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
1.2ug/ml
Thiopental SodiumDrug
2.0ug/ml
Dexmedetomidine HydrochlorideDrug
0.5ng/ml
Midazolam HydrochlorideDrug
60ng/ml
placeboDrug
intralipid, saline, saline with multi-Vit solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Propofol |
| 2 | Experimental | Not described Receives: Drug: Thiopental Sodium |
| 3 | Experimental | Not described Receives: Drug: Dexmedetomidine Hydrochloride |
| 4 | Experimental | Not described Receives: Drug: Midazolam Hydrochloride |
| 5 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: over a two day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory LossesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kane O. Pryor, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142493
- Sponsor's protocol ID
- 04-087
- Status last verified
- Dec 2015
- First submitted
- 31 Aug 2005
- Last updated
- 24 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Affective Content on Drug Induced Amnesia of Episodic Memory
- ClinicalTrials.gov ID
- NCT00142493
- Acronym / sponsor ID
- 04-087
- Conditions
- Memory Losses, Amnesia-Memory Loss
- Keywords
- Episodic Memory, Amnesia, Amnesia, Temporary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Propofol |
| 2 | Experimental | Drug: Thiopental Sodium |
| 3 | Experimental | Drug: Dexmedetomidine Hydrochloride |
| 4 | Experimental | Drug: Midazolam Hydrochloride |
| 5 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol1.2ug/ml | Drug | 1 |
| Thiopental Sodium2.0ug/ml | Drug | 2 |
| Dexmedetomidine Hydrochloride0.5ng/ml | Drug | 3 |
| Midazolam Hydrochloride60ng/ml | Drug | 4 |
| placebointralipid, saline, saline with multi-Vit solution | Drug | 5 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kane O. Pryor, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propofol, Thiopental Sodium and Dexmedetomidine Hydrochloride in people with Memory Losses and Amnesia-Memory Loss, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.