Norepinephrine Transporter Imaging in Addiction Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marc Potenza, Yale University
ClinicalTrials.gov Identifier:
NCT01719458
First received: October 29, 2012
Last updated: March 10, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Estimated Enrollment: 72
Study Start Date: July 2007
Estimated Study Completion Date: July 2014
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
Study Population

24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24 individually matched healthy control subjects

Criteria

Inclusion Criteria:

  1. age 18-50 years inclusive;
  2. able to read and write English;
  3. 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;
  4. 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;
  5. 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
  6. 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:

  1. 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;
  2. use of any psychoactive medication within past three weeks;
  3. 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;
  4. IQ<70 based on past intelligence testing;
  5. any metal in body that would pose a risk with MRI; and
  6. claustrophobia that would interfere with MRI or PET imaging;
  7. presence of alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
  8. pregnancy or nursing for women,
  9. peri- and post- menopausal women, and those with ovarectomies will be excluded
  10. current eating disorders, including binge eating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719458

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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: March 10, 2014
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 July 20, 2014