Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01036516
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-12-18
Brief Title:
PET Assays of Striatal Dopamine Marker in Cocaine Craving
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Assays of Striatal Dopamine Markers in Cocaine Craving
Status:
COMPLETED
Status Verified Date:
2012-03-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Cues related to past drug use induce a particular pattern of brain activation which has been correlated with craving for cocaine in active cocaine abusers Researchers are interested in determining the role of the brain chemical dopamine in cue-elicited as well as spontaneous craving for cocaine
To study the role of dopamine in cocaine craving researchers will use positron emission tomography PET to compare the neural reactions of cocaine users with those of non-substance-abusing healthy volunteers Researchers hope that the data gathered from this study will lead to the development of more effective anti-craving medications
Objectives
To clarify the role of dopamine in cue-elicited responses that contribute to cocaine abuse
To determine if PET results of this study differ with various means of administering PET chemicals
Eligibility
- Individuals 21 to 44 years of age who are either current cocaine users at least twice per week or healthy volunteers without a history of drug abuse
Design
Cocaine-using participants will enter the inpatient clinical research ward at the National Institute on Drug Abuse NIDA Addiction Research Center for 2 nights before the day of the study In addition these participants will stay overnight at NIDA the evening after each PET session and will be discharged the following day Cocaine-using participants will be required to perform a balance test before the study to provide a baseline response in case they require anti-anxiety medications to cope with the effects of the study
Control subjects will not be required to stay overnight and will arrive as outpatients for the PET session All participants will be required to abstain from alcohol and caffeine consumption from midnight before each study session and will not be permitted to smoke on the day of testing
- On the day of the study participants will undergo a practice session to set up the PET scanning equipment Following the practice session participants will be shown video recordings of images that are related to nature eg seashells or to drug abuse eg drug paraphernalia Participant reactions will be studied through the PET monitoring and the study will be conducted in two separate PET sessions with a break in between Individuals in the cocaine-using group may receive anti-anxiety medication if the stimulus cues increase anxiety related to cocaine craving
Different groups of participants will receive different methods of PET chemical administration and researchers will compare these methods
Cues related to past drug use induce a particular pattern of brain activation which has been correlated with craving for cocaine in active cocaine abusers Researchers are interested in determining the role of the brain chemical dopamine in cue-elicited as well as spontaneous craving for cocaine
To study the role of dopamine in cocaine craving researchers will use positron emission tomography PET to compare the neural reactions of cocaine users with those of non-substance-abusing healthy volunteers Researchers hope that the data gathered from this study will lead to the development of more effective anti-craving medications
Objectives
To clarify the role of dopamine in cue-elicited responses that contribute to cocaine abuse
To determine if PET results of this study differ with various means of administering PET chemicals
Eligibility
- Individuals 21 to 44 years of age who are either current cocaine users at least twice per week or healthy volunteers without a history of drug abuse
Design
Cocaine-using participants will enter the inpatient clinical research ward at the National Institute on Drug Abuse NIDA Addiction Research Center for 2 nights before the day of the study In addition these participants will stay overnight at NIDA the evening after each PET session and will be discharged the following day Cocaine-using participants will be required to perform a balance test before the study to provide a baseline response in case they require anti-anxiety medications to cope with the effects of the study
Control subjects will not be required to stay overnight and will arrive as outpatients for the PET session All participants will be required to abstain from alcohol and caffeine consumption from midnight before each study session and will not be permitted to smoke on the day of testing
- On the day of the study participants will undergo a practice session to set up the PET scanning equipment Following the practice session participants will be shown video recordings of images that are related to nature eg seashells or to drug abuse eg drug paraphernalia Participant reactions will be studied through the PET monitoring and the study will be conducted in two separate PET sessions with a break in between Individuals in the cocaine-using group may receive anti-anxiety medication if the stimulus cues increase anxiety related to cocaine craving
Different groups of participants will receive different methods of PET chemical administration and researchers will compare these methods
Detailed Description:
Cues related to past drug use induce a particular pattern of brain activation which has been correlated with craving for cocaine in active cocaine abusers The proposed research is designed to assess the role of dopamine in cue-elicited as well as spontaneous craving for cocaine Cocaine abusers and control subjects will be presented with a stimulus complex related to drug abuse cocaine cues videotape depicting drug use drug paraphernalia or to nature neutral cues videotape depicting items such as shells and pinecones The effects of each cue condition on striatal D2-like dopamine DA receptors and changes in intrasynaptic dopamine will be measured by positron emission tomography PET The PET data will then be correlated with subjective self-reports of mood particularly measures of craving These results will be compared between the two subject groups This research will help clarify the role of dopamine in cue-elicited responses that contribute to cocaine abuse Ultimately the results obtained may lead to the development of anti-craving medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-DA-N391 | None | None | None |