Neural SystemsNCT01036516
PET Assays of Striatal Dopamine Marker in Cocaine Craving
An observational study of Neural Systems and Drug Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Neural Systems, Drug Abuse, Cocaine Dependence
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 1998to 27 Mar 2012
- Phase
- Observational
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Subjects in both the cocaine abuser and control groups will be volunteers of either gender, aged 21 to 44 years.
- History of Drug Abuse: For the cocaine abuser group, regular current use of cocaine is required (at least twice per week) that has been ongoing for at least two years.
Who cannot join
- Psychiatric disease: DSM IV criteria will be used. No subject with a current axis I diagnosis other than a substance abuse disorder will be allowed. No subject with a lifetime history of a schizophrenic disorder will be allowed.
- History of Drug Abuse: Cocaine users will be excluded if toxicology screen at the time of obtaining informed consent is positive for any illicit drug other than cocaine. Volunteers for the control group with any history of intravenous drug abuse or any history of psychostimulant drug abuse will be excluded. Axis I diagnoses of substance abuse disorders other than nicotine abuse and/or dependence will be exclusionary criteria for volunteers in control group.
- CNS disease: Structural brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), history of other neurological disease, or history of head trauma (defined as loss of consciousness > 2 min or requiring hospitalization).
- Cardiovascular disease: Advanced coronary artery disease, endocarditis or other cardiac disease likely to result in cerebral embolism.
- Pulmonary disease: Significant obstructive pulmonary disease, tuberculosis, or bronchospasm (asthma, emphysema, bronchitis).
- Systemic disease: Endocrinopathies, renal or hepatic failure, or autoimmune disease involving the CNS.
Show all 13Show fewer
- Miscellaneous: Hematocrit < 35-36 (for women) or < 39 (for men), prostatic hypertrophy or chronic inflammation.
- Claustrophobia: Subjects will be questioned about their potential discomfort in being in an enclosed space, such as a PET or MRI scanner.
- Because of the potentially harmful effects of radiation exposure to fetuses and infants, female subjects who are pregnant, nursing, planning to become pregnant or who do not show evidence of reliable birth control will be excluded from participation.
- Arterial circulation to the hand: Evidence of inadequate patency of radial and ulnar arteries, determined by either Doppler flow measurements or a positive Allen's test, is an exclusionary criterion for insertion of an arterial catheter. Potential subjects who do not have adequate arterial circulation in their hand but otherwise meet criteria could be included in this study and have only venous blood samples drawn.
- Radiation exposure: Any subject who has had sufficient prior radiation exposure for research purposes (i.e., apart from medical procedures for diagnostic or therapeutic purposes) prior to beginning the study that exceeds 5.0 rem during the previous 12 months or 3.0 rem during the previous 3 months will be excluded.
- Other medication: Volunteers who are currently taking any psychoactive medication, or are currently prescribed other drugs that affect central neurotransmitter systems, will be excluded from this study.
- HIV positive individuals will be excluded because HIV infection and the development of AIDS produces abnormalities in brain function, and in particular in the basal ganglia (Rottenberg et al., 1987), where we propose to make measurements of [11C] raclopride binding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET Assays of Striatal Dopamine Markers in Cocaine Craving
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.
Read more
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 (e.g., seashells) or to drug abuse (e.g., 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.
Read the 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.
- Conditions
- Neural Systems, Drug Abuse, Cocaine Dependence
- Keywords
- Drug Cues, Dopamine Release, Psychomotor Stimulants, D2 Dopamine Receptor Subtype, Neuroimaging
- Medical subject headings
- Substance-Related Disorders, Cocaine-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start23 Jun 1998
- Study completion27 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neural SystemsStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael T Collins, M.D., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036516
- Sponsor's protocol ID
- 999998391
- Other IDs
- 98-DA-N391
- Status last verified
- 27 Mar 2012
- First submitted
- 18 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Berger SP, Hall S, Mickalian JD, Reid MS, Crawford CA, Delucchi K, Carr K, Hall S. Haloperidol antagonism of cue-elicited cocaine craving. Lancet. 1996 Feb 24;347(9000):504-8. doi: 10.1016/s0140-6736(96)91139-3.
PubMed 8596268Breier A, Su TP, Saunders R, Carson RE, Kolachana BS, de Bartolomeis A, Weinberger DR, Weisenfeld N, Malhotra AK, Eckelman WC, Pickar D. Schizophrenia is associated with elevated amphetamine-induced synaptic dopamine concentrations: evidence from a novel positron emission tomography method. Proc Natl Acad Sci U S A. 1997 Mar 18;94(6):2569-74. doi: 10.1073/pnas.94.6.2569.
PubMed 9122236
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Assays of Striatal Dopamine Markers in Cocaine Craving
- ClinicalTrials.gov ID
- NCT01036516
- Acronym / sponsor ID
- 999998391
- Conditions
- Neural Systems, Drug Abuse, Cocaine Dependence
- Keywords
- Drug Cues, Dopamine Release, Psychomotor Stimulants, D2 Dopamine Receptor Subtype, Neuroimaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 23 Jun 1998
- Study completion
- 27 Mar 2012
- First posted
- 21 Dec 2009 (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.
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 (e.g., seashells) or to drug abuse (e.g., 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (13 listed)
- Psychiatric disease: DSM IV criteria will be used. No subject with a current axis I diagnosis other than a substance abuse disorder will be allowed. No subject with a lifetime history of a schizophrenic disorder will be allowed.
- History of Drug Abuse: Cocaine users will be excluded if toxicology screen at the time of obtaining informed consent is positive for any illicit drug other than cocaine. Volunteers for the control group with any history of intravenous drug abuse or any history of psychostimulant drug abuse will be excluded. Axis I diagnoses of substance abuse disorders other than nicotine abuse and/or dependence will be exclusionary criteria for volunteers in control group.
- CNS disease: Structural brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), history of other neurological disease, or history of head trauma (defined as loss of consciousness > 2 min or requiring hospitalization).
- Cardiovascular disease: Advanced coronary artery disease, endocarditis or other cardiac disease likely to result in cerebral embolism.
- Pulmonary disease: Significant obstructive pulmonary disease, tuberculosis, or bronchospasm (asthma, emphysema, bronchitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 8596268Berger SP, Hall S, Mickalian JD, Reid MS, Crawford CA, Delucchi K, Carr K, Hall S. Haloperidol antagonism of cue-elicited cocaine craving. Lancet. 1996 Feb 24;347(9000):504-8. doi: 10.1016/s0140-6736(96)91139-3.
- Background: PubMed 9122236Breier A, Su TP, Saunders R, Carson RE, Kolachana BS, de Bartolomeis A, Weinberger DR, Weisenfeld N, Malhotra AK, Eckelman WC, Pickar D. Schizophrenia is associated with elevated amphetamine-induced synaptic dopamine concentrations: evidence from a novel positron emission tomography method. Proc Natl Acad Sci U S A. 1997 Mar 18;94(6):2569-74. doi: 10.1073/pnas.94.6.2569.
Related trials for Neural Systems
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Enrolling by invitation
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
Epilepsy, Speech
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
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.
Michael T Collins, M.D. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Systems and Drug Abuse, run by National Institute on Drug Abuse (NIDA) 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 2 inclusion and 13 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 2 Jul 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036516, which also lists 2 linked publications.
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 2 Jul 2017.