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PET Imaging for Substance Use Disorders

Phase < 1

Recruiting

Led By Kelly Cosgrove, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not treatment seeking or using treatment medications

Men and women, aged 18-55 years

Must not have

History of or current neurological or significant psychiatric disorder such as schizophrenia or bipolar disorder (DSM-IV Axis 1)

Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minute pet scan acquisition. drug of dependence will be given at -35 mins

Awards & highlights

No Placebo-Only Group

Summary

This trialwill use PET technology to study the effects of drugs of abuse (marijuana, cigs, cocaine) on dopamine and opioid systems.

Who is the study for?

This trial is for men and women aged 18-55 who smoke tobacco regularly or use marijuana but are not seeking treatment. Participants must be able to consent in English, have a certain level of nicotine dependence, and not use other illicit drugs or significant medications. Pregnant/nursing women, those with major medical/psychiatric conditions, or MRI-incompatible implants cannot join.

What is being tested?

The study uses PET scans to examine the effects of substances like marijuana, cigarettes, and cocaine on dopamine and opioid neurotransmitter systems in the brain. It aims to advance understanding of drug addiction's neurochemistry using cutting-edge imaging technology.

What are the potential side effects?

While the document does not specify side effects from PET scanning itself, common ones can include discomfort at injection site for tracer substance used in PET scan; allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently seeking or using any treatment medications.

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of major psychiatric disorders like schizophrenia or bipolar.

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I am not pregnant or nursing and use effective birth control or am surgically sterile/postmenopausal.

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I have a serious health condition affecting my brain, heart, hormones, kidneys, liver, or thyroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 minute pet scan acquisition. drug of dependence will be given at -35 mins

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 minute pet scan acquisition. drug of dependence will be given at -35 mins

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minute pet scan acquisition. drug of dependence will be given at -35 mins for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in beta endorphin levels at baseline and after drug of dependence administration as confirmed by PET images.

Change in dopamine levels at baseline and after drug of dependence administration as confirmed by PET images.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Drug of dependenceExperimental Treatment1 Intervention

There is only one arm to the study. All subjects will receive their drug of dependence in this study. Nicotine dependent subjects will receive tobacco cigarettes, cannabis dependent subjects will receive cannabis cigarettes, and cocaine dependent subjects will receive IV cocaine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cannabis

2013

Completed Phase 1

~440

0 / 5Eligibility criteria met