CompletedPhase 2

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

United States32 participantsStarted 2020-12-18

Plain-language summary

The overarching goal of this project is to examine the effect of combining theta burst stimulation (TBS) and N-acetylcysteine (NAC) on cocaine craving and brain response to cocaine-related images.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
✕. Any physical or intellectual disability affecting completion of assessments
✕. Any contraindication to MRI
✕. Current or past psychosis
✕. ECT in last 6 months
✕. Among females, pregnancy at screening will be exclusionary. Females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fMRI scanning session and regularly before and during the medication trial. They must further agree to notify the study physician or PA if they become pregnant during the study.
✕. Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA \> 8 will be excluded.
✕. Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)

What they're measuring

Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)

Timeframe: From baseline to immediately post-TBS

Change in POMS Score From Baseline to Post-TBS"

Timeframe: From baseline to immediately post-TBS

Change in Cocaine Craving Rating From Baseline to Post-TBS

Timeframe: From baseline to immediately post-TBS

Trial details

NCT IDNCT04155632

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-09

Results submitted2025-06-30

View on ClinicalTrials.gov More Cocaine-Related Disorders trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
✕. Any physical or intellectual disability affecting completion of assessments
✕. Any contraindication to MRI
✕. Current or past psychosis
✕. ECT in last 6 months
✕. Among females, pregnancy at screening will be exclusionary. Females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fMRI scanning session and regularly before and during the medication trial. They must further agree to notify the study physician or PA if they become pregnant during the study.
✕. Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA \> 8 will be excluded.
✕. Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)

What they're measuring

Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)

Timeframe: From baseline to immediately post-TBS

Change in POMS Score From Baseline to Post-TBS"

Timeframe: From baseline to immediately post-TBS

Change in Cocaine Craving Rating From Baseline to Post-TBS

Timeframe: From baseline to immediately post-TBS