Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving

NCT01929343 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STU 032013-049
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

We propose that the systemic administration of lidocaine following the induction of cue-induced craving, relative to saline plus cue-induced craving or lidocaine without cue-induced craving, will block the reconsolidation of cue memories. This will lead to a reduction in cue-induced craving upon repeated testing as well as subsequent cocaine use and basal craving.

Conditions

Cocaine Addiction

Keywords

cocaine; addiction; lidocaine; memory; drug abuse

Outcome Measures

Primary Outcomes (5)

• Cue-induced Craving After Lidocaine/Saline Administration.

  7 days after lidocaine/saline administration, cocaine craving will be measured during the administration of relaxation or craving script. Craving intensity will be measured by the subjective intensity of craving as reported by the participant. Measured via a visual analog scale based on 4 (out of 10) questions from the Cocaine Craving Questionnaire (1-strongly disagree to 7- strongly agree). Highest total score possible 28, lowest score possible is 4. If the score is low in the lidocaine group and high in the saline group, it would mean that lidocaine has successfully decreased the craving response relative to saline.

  craving measured immediately following reading of the script.

• Physiological Responses as Measured by Heart Rate After Lidocaine/Saline Administration.

  7 days after lidocaine/saline administration, heart rate will be measured during the administration of a relaxation or craving script. Heart rate will be measured in beats per minute.

  120 seconds, during reading of the script.

• Physiological Responses as Measured by Blood Pressure After Lidocaine/Saline Administration.

  7 days after lidocaine/saline administration, blood pressure (BP) response will be assessed during relaxation or craving script. Blood pressure will be measured by mmHg.

  BP will measured during the two minutes of script reading.

• Physiological Responses as Measured by Galvanic Skin Response (GSR) After Lidocaine/Saline Administration.

  7 days after lidocaine/saline administration, GSR will be measured during the reading of the relaxation or saline script. It is predicted that higher GSR would be associated with higher cocaine craving and lower GSR will be associated with lower cocaine craving.

  2 minutes during script reading.

• Physiological Responses as Measured by EMG (Electromyography) After Lidocaine/Saline Administration.

  Electromyography (frontal) will be measured during the administration of the relaxation or craving script seven days after infusion. EMG is assessed by uV (microvolts). Higher scores reflect greater amounts of EMG activity, lower scores reflect lower amounts of EMG activity. It was expected that EMG would be positively associated with cocaine craving.

  2 minutes during administration of script.

Secondary Outcomes (2)

• Cocaine Use

  cocaine use will be measure during the 4 weeks following infusion

• Cocaine Craving

  cocaine craving will be measure during the 4 weeks following infusion

Study Arms (3)

lidocaine following cue-induced craving

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.

Drug: lidocaine following cue-induced craving

lidocaine following neutral stimulus

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.

Drug: lidocaine following neutral stimulus

saline

PLACEBO COMPARATOR

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

Drug: saline

Interventions

lidocaine following cue-induced craving DRUG

as described in Arm Description

Also known as: Xylocaine

lidocaine following cue-induced craving

lidocaine following neutral stimulus DRUG

as described in Arm Description

Also known as: Xylocaine

lidocaine following neutral stimulus

saline DRUG

as described in Arm Description

Also known as: 0.9% Sodium chloride

saline

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• men or women
• any race or ethnicity
• cocaine addition is primary present and lifetime drug of abuse
• live locally

You may not qualify if:

• 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.
• Patients with congenital or idiopathic methemoglobinemia or patients taking medications associated with increased risk of methemoglobinemia (including sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, paraaminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine) will be excluded.
• Patients with past or present neurologic disorders (i.e. severe head trauma, transient ischemic attacks, stroke, tumor, etc.) will be excluded. - Active suicidal ideation, pregnant or nursing women, and prisoners will be excluded from the study.

Sponsors & Collaborators

• Bryon Adinoff: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas, Division on Addictions

Dallas, Texas, 75390-8564, United States

Location

Related Publications (1)

• Becker JE, Price JL, Leonard D, Suris A, Kandil E, Shaw M, Kroener S, Brown ES, Adinoff B. The Efficacy of Lidocaine in Disrupting Cocaine Cue-Induced Memory Reconsolidation. Drug Alcohol Depend. 2020 Jul 1;212:108062. doi: 10.1016/j.drugalcdep.2020.108062. Epub 2020 May 12.

  PMID: 32480252 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive; Substance-Related Disorders

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Within the Primary outcome measure- 'Physiological Responses as Measured by Blood Pressure After Lidocaine/Saline Administration', we're unable to report this as it was not actually an outcome of interest and so was not analyzed.

Results Point of Contact

• Title: Josh Becker
• Organization: UT Southwestern Medical Center

joshua.becker@utsouthwestern.edu

2146485277

Study Officials

• Bryon Adinoff, MD

  UT Southwestern Medical Center, VA North Texas Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 27, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Locations

US (1)