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Cocaine Dependence clinical trials

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NCT ID: NCT06189690 Recruiting - Cocaine Dependence Clinical Trials

Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

Start date: January 6, 2022
Phase: N/A
Study type: Interventional

This study aims to explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF, craving and cognitive function. This study will be longitudinal, with a short-term double-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase, consisting of 2 weekly sessions for 12 weeks. Participants will be clinically assessed pre-treatment (T0), after 20-sessions phase (T1) and after 12-weeks phase (T2) by an interview about psychiatric symptoms. Also, blood will be obtained in the same T0, T1 and T2 to peripheral levels of BDNF determination. Cognitive state will be measured at the same time-points (T0, T1, T2) by paper-pencil and computerized neuropsychological assessment. Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables. Additionally, a comparative group (without rTMS intervention) will be included to equivalently measure described variables during periods without cocaine consumption.

NCT ID: NCT06159387 Recruiting - Cocaine Dependence Clinical Trials

Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

Start date: October 23, 2023
Phase: Phase 4
Study type: Interventional

2.1. General To evaluate the efficacy and safety of a Cannabis sativa extract (CBD (Cannabidiol) + up to 0.3% THC (Delta-9-tetrahydrocannabinol)), compared to placebo, in the treatment of cocaine/crack use disorder. 2.2. Specifics - Compare the amount and frequency of cocaine use between the group treated with Cannabis sativa extract and the placebo group - Compare adherence to treatment between the group treated with Cannabis sativa extract and the placebo group - Evaluate the prevalence and intensity of depressive and anxious symptoms in patients using Cannabis sativa extract compared to patients using placebo - Evaluate the incidence and severity of side effects in the active group compared to placebo.

NCT ID: NCT06125054 Recruiting - Cocaine Dependence Clinical Trials

Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction

Co-Boost
Start date: February 5, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training in individuals with cocaine use disorder. The main questions the investigators aim to answer are: - Can the investigators observe a positive, significant effect on percentage of cocaine use days of both interventions combined as well as stand alone interventions? - Is there a significant transfer effect of the neurofeedback training? - Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine and a realtime fMRI neurofeedback training. Both interventions are placebo-controlled. The investigators will compare the four intervention groups to investigate the effects of the stand-alone effects of the intervention and the combination of it.

NCT ID: NCT05974202 Not yet recruiting - Cocaine Dependence Clinical Trials

rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

Start date: September 15, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to answer are: - Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use disorder? - What is the brain mechanism of rTMS? - Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use disorder achieve abstinence from cocaine? Participants will: - Have two brain MRI scans; - Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and; - Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder. Researchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will receive cognitive-behavioral therapy.

NCT ID: NCT05857852 Recruiting - Cocaine Dependence Clinical Trials

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This study aims to understand the role of Low-Intensity Focused Ultrasound on craving levels for cocaine as evidenced by diagnostic imaging of the dorsal anterior insula (dAI) and subjective ratings. Data analysis will serve to show if 1) LIFU is safe and effective and to 2) examine the effects of LIFU on dAI BOLD activity and craving in response to cocaine cue-exposure. The study will screen 60 individuals with Cocaine Use Disorder (CUD) to arrive at 30 enrolled subjects, based on a 2:1 screen/randomization ratio.

NCT ID: NCT05824221 Not yet recruiting - Cocaine Dependence Clinical Trials

Effect of rTMS on Neurotrophines Levels in CUD

BDNFcoca
Start date: April 30, 2023
Phase: N/A
Study type: Interventional

Brief Summary: Background: Cocaine use disorders (CUD) is a multifactoral disease, involving several brain areas. One of the most investigated is the Dorsolateral Prefrontal Cortex (DLPFC) involved in impulsiveness control. Effective treatments for CUD are still needed and repetitive Transcranial Magnetic Stimulation (rTMS) is widely studied for its potential in reducing cocaine craving and consumption. Objectives: The main outcome is to test if rTMS can be related to neuroplasticity and neurotrophism through changes in Brain-Derived Neurotrophic Factor (BDNF) and its precursor (pro-BDNF) levels. Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe). Design: This is a randomized, sham-controlled study. The study includes a rTMS continued treatment phase compared to healthy control (HC) evaluation. Prior to participating, participants will be screened with: - Medical history - Anamnestic sheet - Physical exam - Urine tests After being enrolled, participants and HC will undergo venous blood sample (BDNF and proBDNF levels). During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or sham rTMS; a former arm is also provided and is made up of HC. RTMS will be delivered in 10 days, over 2 weeks (5 days/week). After the last rTMS session a blood sample for neurotrophines levels will be collected. Treatment includes: - rTMS: A coil is placed on the head. At each session, participants will receive two rTMS sessions, with a 50 mins interval. At the beginning of each rTMS session, they view cocaine-related images for few minutes (cue-induced stimuli). - BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first two weeks), this sample will be also collected from HC. The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. - Urine toxicological screen

NCT ID: NCT05562349 Active, not recruiting - Cocaine Dependence Clinical Trials

Clavulanic Acid for the Treatment of Cocaine Use Disorder

Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)

NCT ID: NCT04994821 Recruiting - Cocaine Dependence Clinical Trials

tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

Start date: September 28, 2020
Phase: Phase 2
Study type: Interventional

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.

NCT ID: NCT04907357 Active, not recruiting - Cocaine Dependence Clinical Trials

rTMS for Stimulant Use Disorders

CTN-0108
Start date: February 4, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to determine feasibility of repetitive transcranial magnetic stimulation (rTMS) for individuals with moderate to severe cocaine or methamphetamine use disorder (CUD/MUD). Potential participants will be age 18-65, and interested in cutting down or stopping use. Participants will be randomized to one of two groups; groups will receive rTMS or sham rTMS (placebo) over the course of an 8-week treatment period, and complete follow-up assessments at the end of treatment, 12, and 16 weeks post-randomization.

NCT ID: NCT04411914 Completed - Cocaine Dependence Clinical Trials

Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid

Start date: September 1, 2020
Phase: Phase 1
Study type: Interventional

A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.