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Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving

Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Addiction

Intervention: lidocaine following cue-induced craving (Drug); lidocaine following neutral stimulus (Drug); saline (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Bryon Adinoff, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center, VA North Texas Health Care System

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.

Clinical Details

Official title: Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving

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

Primary outcome:

Cue-induced craving after lidocaine/saline administration.

Physiological responses after lidocaine/saline administration.

Secondary outcome:

cocaine use

cocaine craving

Detailed description: Cocaine dependence is among the most tenacious of the substance use disorders yet remains one of the few lacking an effective pharmacological intervention. As other pharmacologic approaches have not been fruitful, new targets are required. A novel treatment approach is to disrupt the neural processes involved in cue-related memories (memory links between the external stimuli associated with drug use and the subjective drug effect). These engrained memories, when reactivated by cues, elicit craving and a return to drug use. Each cue re-exposure, however, requires the re-remembering (or reconsolidation) of the drug cue. Key molecular processes required for memory reconsolidation are NMDA (N-methyl-D-aspartate) receptor activation, the induction of nitric oxide (NO) synthesis and increased extracellular signal-regulated kinase (ERK) activity. In rodent models, blocking these processes changes the cue-related memory; the cue loses its potency to induce a return to drug self-administration. Lidocaine is an FDA approved medication that inhibits activation of NMDA receptors and suppresses production of NO and ERK. Lidocaine, like cocaine, is a local anesthetic with potent effects as a sodium-channel blocker. Unlike cocaine, lidocaine is essentially devoid of activity at monoamine re-uptake transporters and has no rewarding or addictive properties. As lidocaine suppresses the molecular processes required for drug cue reconsolidation and has relatively specific effects upon the striatal regions necessary for drug cue reconsolidation, lidocaine may offer a novel approach for interfering with memory reconsolidation. Two other Na+ channel blockers have also decrease craving and/or substance use in substance-dependent subjects. 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. If our hypotheses are proven correct, these findings will 1) support a role for lidocaine in cocaine addiction treatment, 2) demonstrate the feasibility and efficacy of attenuating cue-induced memories, and 3) guide the development of a larger study with lidocaine.

Eligibility

Minimum age: 25 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 25-60 years old

- men or women

- any race or ethnicity

- cocaine addition is primary present and lifetime drug of abuse

- live locally

Exclusion Criteria:

- 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).

- 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.

Locations and Contacts

UT Southwestern Medical Center at Dallas, Division on Addictions, Dallas, Texas 75390-8564, United States; Recruiting
Bryon Adinoff, M.D., Phone: 214-645-6975, Email: bryon.adinoff@utsouthwestern.edu
Currie Hawkins, Phone: 214-645-6975, Email: robbi.banks@utsouthwestern.edu
Bryon Adinoff, M.D., Principal Investigator
Additional Information

Starting date: January 2014
Last updated: May 29, 2015

Page last updated: August 23, 2015

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