Norepinephrine Transporter Imaging in Addiction Disorders
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Purpose
In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24 individually matched healthy control subjects and determine Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.
| Condition | Intervention |
|---|---|
|
Obesity Alcohol Dependence |
Drug: (S,S)-[11C]MRB |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Norepinephrine Transporter Imaging in Addiction Disorders |
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Alcohol
Subjects diagnosed with alcohol dependence
|
Drug: (S,S)-[11C]MRB
PET radioligand
|
|
Obese
Subjects diagnosed with obesity
|
Drug: (S,S)-[11C]MRB
PET radioligand
|
|
Healthy
Subjects deemed to be medically healthy
|
Drug: (S,S)-[11C]MRB
PET radioligand
|
Detailed Description:
In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24 individually matched healthy control subjects and determine NET expression in vivo using (S,S)-[11C]MRB and PET. This will provide novel insight into alterations in pre- and post-synaptic homeostasis in alcoholism and obese people with the goal to explain regulatory processes and their alterations in these disorders. A better understanding of brain mechanisms and contributory stress would have an enormous impact on the public's understanding of the vulnerabilities for these disorders, influence medical and legal response to these problems, could lead to a new understanding of these phenomena, and stimulate a better means of prevention and treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24 individually matched healthy control subjects
Inclusion Criteria:
- age 18-50 years inclusive;
- able to read and write English;
- for women, being in follicular phase of menstrual cycle at the time of the PET scan as determined by calculating the time since the last menses and assessments of serum hormone levels;
- 30 < BMI < 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the MRI scanner) and 18.5 < BMI <25 for normal weight subjects, and no recent weight changes in prior 12 weeks prior to the study;
- for alcohol dependent patients meet current DSM-IV criteria for alcohol dependence or being in partial remission; abstinence on the MRI and PET scan days will be determined by patient self-report, breath alcohol tests (BACs) conducted during inpatient stay at the CNRU/GCRC, participants have to be non-obese BMI < 30, and
- for current daily smokers, having smoked 10 or more cigarettes daily for the past year and CO level > 10 ppm at intake; for non-smokers, no tobacco consumption for more than one year and never having used tobacco daily.
Exclusion Criteria:
- any major neurological illness or injury and any current or prior clinically significant mental health or substance use disorder (with possible exception of nicotine dependence and alcohol dependence per the inclusion criteria) as determined by SCID interview and the judgement of the PI;
- use of any psychoactive medication within past three weeks;
- any significant unstable medical condition such as asthma or heart disease which may limit the interpretation of the imaging results, for example due to changes in tracer delivery in hypertensive patients;
- IQ<70 based on past intelligence testing;
- any metal in body that would pose a risk with MRI; and
- claustrophobia that would interfere with MRI or PET imaging;
- presence of alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
- pregnancy or nursing for women,
- peri- and post- menopausal women, and those with ovarectomies will be excluded
- current eating disorders, including binge eating.
Contacts and Locations| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Marc N Potenza, MD, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Marc Potenza, Professor of Psychiatry, Child Study, and Neurobiology, Yale University |
| ClinicalTrials.gov Identifier: | NCT01719458 History of Changes |
| Other Study ID Numbers: | 0705002688, RL1AA017540 |
| Study First Received: | October 29, 2012 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alcoholism Obesity Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Norepinephrine Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013