Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving (LIDO)
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|ClinicalTrials.gov Identifier: NCT01929343|
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : December 31, 2020
Last Update Posted : December 31, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Cocaine Addiction||Drug: lidocaine following cue-induced craving Drug: lidocaine following neutral stimulus Drug: saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: lidocaine following cue-induced craving
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
as described in Arm Description
Other Name: Xylocaine
Active Comparator: lidocaine following neutral stimulus
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
as described in Arm Description
Other Name: Xylocaine
Placebo Comparator: saline
Saline will be administered at same volume of lidocaine in active arms.
as described in Arm Description
Other Name: 0.9% Sodium chloride
- Cue-induced Craving After Lidocaine/Saline Administration. [ Time Frame: craving measured immediately following reading of the script. ]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.
- Physiological Responses as Measured by Heart Rate After Lidocaine/Saline Administration. [ Time Frame: 120 seconds, during reading of the script. ]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.
- Physiological Responses as Measured by Blood Pressure After Lidocaine/Saline Administration. [ Time Frame: BP will measured during the two minutes of script reading. ]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.
- Physiological Responses as Measured by Galvanic Skin Response (GSR) After Lidocaine/Saline Administration. [ Time Frame: 2 minutes during script reading. ]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.
- Physiological Responses as Measured by EMG (Electromyography) After Lidocaine/Saline Administration. [ Time Frame: 2 minutes during administration of script. ]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.
- Cocaine Use [ Time Frame: cocaine use will be measure during the 4 weeks following infusion ]cocaine use will be measured by urine drug screen and participant self-report three times weekly after lidocaine/saline administration. Cocaine use will be assessed as positive (1) or negative (0) using urine drug screen for cocaine and/or by participant self-report of cocaine use.
- Cocaine Craving [ Time Frame: cocaine craving will be measure during the 4 weeks following infusion ]basal measures of cocaine craving will be measured by Cocaine Craving Questionnaire (CCQ) times weekly after lidocaine/saline administration. The higher the score the more craving and lower the score the less craving. The CCQ has 10 items, each item scored 1-7. Maximum score is 70, minimum score is 7.
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|Ages Eligible for Study:||25 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 25-60 years old
- men or women
- any race or ethnicity
- cocaine addition is primary present and lifetime drug of abuse
- live locally
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929343
|United States, Texas|
|UT Southwestern Medical Center at Dallas, Division on Addictions|
|Dallas, Texas, United States, 75390-8564|
|Principal Investigator:||Bryon Adinoff, MD||UT Southwestern Medical Center, VA North Texas Health Care System|
Documents provided by Bryon Adinoff, University of Texas Southwestern Medical Center:
|Responsible Party:||Bryon Adinoff, Clinical Professor, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 27, 2013 Key Record Dates|
|Results First Posted:||December 31, 2020|
|Last Update Posted:||December 31, 2020|
|Last Verified:||December 2020|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action