Clinical trial for Cocaine Use
Official title rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
ClinicalTrials.gov ID: NCT05974202
What this study is testing
- Who it's for
- People with moderate or severe cocaine use disorder who are willing to undergo brain scans and daily treatments.
- What's involved
- Participants get two brain scans, one week of daily brain stimulation (real or fake), and 12 weeks of weekly talk therapy.
- Time commitment
- The study lasts about 13 weeks, requiring daily visits for the first week and weekly visits for the rest.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Age 22-65;
- Able to give informed consent and comply with study procedures;
- Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking;
- Used cocaine at least 6 days in the past 28 days;
- Agree to no more than moderate alcohol consumption (\<15 drinks/week for men and \<8 drinks/week for women) and to avoid using...
You likely can't join if
- Meets DSM-5 criteria for current moderate or severe major depressive disorder, OCD, bipolar disorder, schizophrenia, or any psychotic disorder (other...
- Hamilton Depression Rating Scale score \> 17;
- Young Mania Rating Scale score \>10;
- Meets DSM-5 criteria for current moderate or severe other substance use disorder (aside from tobacco use disorder).
- Heavy weekly alcohol drinking as defined by an average of \>14 drinks/week for men or \>7 drinks/week for women on average during the past 28 days;
- Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or...
See the full eligibility criteria
Who can join
- Age 22-65;
- Able to give informed consent and comply with study procedures;
- Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking;
- Used cocaine at least 6 days in the past 28 days;
- Agree to no more than moderate alcohol consumption (\<15 drinks/week for men and \<8 drinks/week for women) and to avoid using amphetamine/methamphetamine and non-prescribed benzodiazepines or barbiturates; and
- Women of childbearing potential must agree to use a method of contraception with proven how well it works and agree to not become pregnant during the study.
What rules you out
- Meets DSM-5 criteria for current moderate or severe major depressive disorder, OCD, bipolar disorder, schizophrenia, or any psychotic disorder (other than transient psychosis due to substance use);
- Hamilton Depression Rating Scale score \> 17;
- Young Mania Rating Scale score \>10;
- Meets DSM-5 criteria for current moderate or severe other substance use disorder (aside from tobacco use disorder). Thus physiologic dependence on any substance other than nicotine is exclusionary (including alcohol);
- Heavy weekly alcohol drinking as defined by an average of \>14 drinks/week for men or \>7 drinks/week for women on average during the past 28 days;
- Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;
- Non-prescribed medications/drugs that in the opinion of the investigator may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
- Any current DSM-5 psychiatric disorder(s) that meet the following criteria in the investigator's opinion 1) are unstable, 2) would be worsened by study procedures, or 3) are likely to require acute intervention during...
- Significant current risk of suicide, indicated by either: (1) "yes" response on #3, #4, or #5 on the C-SSRS and a psychiatric risk assessment indicating a moderate or high risk of suicide or (2) suicidal behavior in the...
- Females with a positive urine pregnancy test and/or breast feeding
- Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);
- Seizure history including: seizure disorder/epilepsy, alcohol/drug withdrawal seizure, or seizure deemed by the study physician to be related to cocaine intoxication/withdrawal (note: febrile seizures are not...
- Other conditions associated with seizure: epilepsy and the following acute or subacute neurologic disorders: stroke (ischemic or hemorrhagic), multiple sclerosis, traumatic brain injury (moderate or severe)...
- Medications that lower seizure threshold and in the opinion of the investigator impose significant seizure risk for the individual (including tricyclic antidepressants, monoamine oxidase inhibitors, bupropion...
- Cognitive disorder (MMSE \<25);
- Disqualifying response on the TMS Adult Safety Screen (TASS);
- Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant, implanted brain stimulators)
- Currently taking ototoxic medications (aminoglycosides, cisplatin);
- Metal implants or paramagnetic objects in the body that prohibits MR scanning;
- Claustrophobia that prohibits MR scanning; or
- Legally mandated (e.g., to avoid incarceration or other penalties) to participate in SUD treatment program.
- Moderate to severe heart disease
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.