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WithdrawnNCT01719458Updated Mar 2, 2023

Norepinephrine Transporter Imaging in Addiction Disorders

An observational study in Obesity and Alcohol Dependence, sponsored by Yale University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Yale University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Obesity
  • Alcohol Dependence

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03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

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Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Alcohol

    Subjects diagnosed with alcohol dependence

    Drug: (S,S)-[11C]MRB

  • Obese

    Subjects diagnosed with obesity

    Drug: (S,S)-[11C]MRB

  • Healthy

    Subjects deemed to be medically healthy

    Drug: (S,S)-[11C]MRB

Interventions

  • Drug(S,S)-[11C]MRB

    PET radioligand

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Study locations

1 site
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01719458
Lead sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Marc Potenza (Professor of Psychiatry, Child Study, and Neurobiology, Yale University) — Principal investigator
First posted
Nov 1, 2012
Start date
Jul 2007
Primary completion
Jul 2012
Completion
Jan 4, 2023
Last update
Mar 2, 2023

Study contacts

Marc N Potenza, MD, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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