NCT01719458

Withdrawn

Norepinephrine Transporter Imaging in Addiction Disorders

Yale University Source

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Other study identifiers

Sponsor study identifier

0705002688

Secondary identifiers

RL1AA017540

NIH

Study Type

observational

Actual enrollment (reported)

0

Locations

1 country

Sites

1

Timeline

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2012

Actual (reported)

Study Completion

January 4, 2023

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: January 4, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)
First Submitted
October 29, 2012
Actual (reported)
First Posted
November 1, 2012
Actual (reported)
Study Completion
January 4, 2023
Actual (reported)

Last Updated: March 2, 2023
Status Verified: March 2023
Last Update Submitted: March 1, 2023

Conditions

Alcohol Dependence Obesity

Study Arms (3)

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

(S,S)-[11C]MRBDrug

PET radioligand

AlcoholHealthyObese

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

age 18-50 years inclusive;

Sponsors & Collaborators

Yale University
Otherlead
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIHcollaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

MeSH Terms

Conditions

ObesityAlcoholism

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

Marc N Potenza, MD, PhD
Yale University
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Psychiatry, Child Study, and Neurobiology

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

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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;

\< 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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

July 2012

Actual (reported)

Study Completion

January 4, 2023

Actual (reported)

Last Updated

March 2, 2023

Record last verified: 2023-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01719458
Data provider: ClinicalTrials.gov
Source updated: 2023-03-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:01 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Study Arms (3)

Alcohol

Obese

Healthy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations