Completed

LIDOLidocaine Infusion for Reduced Cocaine Craving and Relapse

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

lidocaine following cue-induced craving

+ lidocaine following neutral stimulus

+ saline

Drug
Who is being recruted

Behavior+5

+ Mental Disorders

+ Compulsive Behavior

From 25 to 60 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorBryon Adinoff
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

This clinical trial focuses on finding a potential treatment for cocaine dependence, a condition that currently lacks effective pharmacological interventions. The study aims to disrupt the neural processes associated with cue-related memories, which are memories linked to drug use that can trigger craving and relapse. The treatment being tested is Lidocaine, an FDA-approved medication that is typically used as a local anesthetic. Lidocaine has been found to inhibit certain molecular processes that are required for memory reconsolidation, and it's hoped that it could help reduce the potency of cue-related memories, thereby decreasing craving and the likelihood of relapse in individuals with cocaine dependence. Participants in this study will receive either Lidocaine or a placebo (saline solution) after being exposed to cues that induce craving. The study will measure the intensity of cocaine craving 7 days after the administration of Lidocaine or saline, using a visual analog scale based on questions from the Cocaine Craving Questionnaire. Additionally, various physiological responses such as blood pressure, electromyography (EMG), galvanic skin response (GSR), and heart rate will be measured during this period. If the study's hypotheses are correct, Lidocaine could potentially reduce cue-induced craving and subsequent cocaine use, offering a novel approach to cocaine addiction treatment.

Official TitleLidocaine Infusion as a Treatment for Cocaine Relapse and Craving
NCT01929343
Principal SponsorBryon Adinoff
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior, AddictiveSubstance-Related DisordersCocaine-Related DisordersChemically-Induced Disorders

Criteria

5 inclusion criteria required to participate
men or women

25-60 years old

any race or ethnicity

cocaine addition is primary present and lifetime drug of abuse

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6 exclusion criteria prevent from participating
Patients with active DSM (Diagnostic Statistical Manual)-IV other Substance Dependence (except nicotine) within the previous three months, Affective Disorder, Schizophrenic Disorders.

significant cognitive impairment (WTAR<70) (Wechsler Test of Adult Reading <70)..

use of tricyclic anti-depressants, benzodiazepines, cimetidine, mood stabilizers, opioids, lithium, sympathomimetics, anticonvulsants, sedative/hypnotics, β-blockers, or dopamine agonists will be excluded from the study.

Medical conditions that might limit cooperation (e.g. dementia) or put the patient at medical risk (i.e. significant hematologic, hepatic, renal, or cardiovascular pathology - particularly arrhythmias) will be excluded.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Lidocaine will be administered immediately following craving induction. Lidocaine will administered at a loading dose of 2mg/kg(milligrams per kilogram) initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.

Group II

Active Comparator
Lidocaine will be administered immediately following neutral stimulus. Lidocaine will administered at a loading dose of 2mg/kg initial bolus over 5 minutes lidocaine followed by continuous infusion at 2mg/kg /hour for 4 hours.

Group III

Placebo
Saline will be administered at same volume of lidocaine in active arms.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UT Southwestern Medical Center at Dallas, Division on Addictions

Dallas, United StatesOpen UT Southwestern Medical Center at Dallas, Division on Addictions in Google Maps
CompletedOne Study Center