Neurocognitive Functioning Following The PROMETA® Treatment Protocol In

Status Recruiting

Clinical Trial Summary

This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment.

Clinical Trial Description

The principal aim of this study is to extend our evaluation of the PROMETA® Treatment Protocol as a means to improve neurocognitive functioning in recently detoxified alcohol dependent subjects. For many alcohol dependent patients entering treatment, a range of neurocognitive deficits are present that not only had adverse effects on the patient's ability to function and think clearly but these deficits also impair the process of addiction treatment. For example, alcohol dependent subjects typically experience high levels of alcohol craving in the early stages of treatment. The patient is left with the choice of relieving craving by drinking alcohol to provide immediate relief of craving symptoms or abstaining from alcohol to obtain long-term benefits from recovery of the complications from excessive drinking. We have previously shown in open label trials that the PROMETA® Treatment Protocol helps stimulant abusers in the early stages of recovery, have relatively low rates of relapse to stimulant use. It is not clear if the Protocol is effective because of less urges to use stimulants or the ability to resist these urges is improved from a recovery of Neurocognitive functioning. The present proposal extends our previous research by comparing the efficacy of the PROMETA® Treatment Protocol in a double blind placebo controlled trial using a new population of substance abusers (alcohol dependent subjects) and assessing the effects of the PROMETA® Treatment Protocol on neurocognitive functioning, particularly those aspects of functioning that affect the ability to make decisions that have important long-term benefits. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00570388
Study type	Interventional
Source	Institute of Addiction Medicine
Contact	Jenny J Starosta, PhD
Phone	215-248-6025
Email	2evolve@gmail.com
Status	Recruiting
Phase	N/A
Start date	March 2007
Completion date	September 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02901041` - Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism	Phase 3
Completed	`NCT03340051` - Remote Alcohol Monitoring and Episodic Thinking	N/A
Not yet recruiting	`NCT06444243` - Psilocybin-assisted Therapy for Alcohol Use Disorder	Phase 2
Completed	`NCT02705898` - Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women	N/A
Completed	`NCT02486900` - Neurofeedback & Alcohol Dependence	N/A
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT02197598` - Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use	Phase 4
Recruiting	`NCT02385643` - The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients	N/A
Completed	`NCT01828866` - Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT02193204` - Chronic Alcohol, Stress Inflammatory Response and Relapse Risk	N/A
Completed	`NCT01342549` - Treatment Strategy for Alcohol Use Disorders in Veterans With TBI	Phase 3
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT01165541` - A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency	Phase 2
Completed	`NCT01056484` - Mindfulness Meditation for Health	Phase 2
Completed	`NCT00585780` - Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse	Phase 1/Phase 2
Completed	`NCT00607620` - Disseminating Organizational SBI Services at Trauma Centers	N/A
Completed	`NCT00884884` - Aripiprazole and Topiramate on Free-Choice Alcohol Use	Phase 2/Phase 3
Completed	`NCT00463346` - Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms