Phase 2
Completed N=33
Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving
Cocaine Addiction
Source: ClinicalTrials.gov NCT01929343 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Cue-induced Craving After Lidocaine/Saline Administration. — 31.7; 17.3; 22.7 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cue-induced Craving After Lidocaine/Saline Administration. |
31.7; 17.3; 22.7 | — |
| PRIMARY Physiological Responses as Measured by Heart Rate After Lidocaine/Saline Administration. |
67.4; 73.0; 77.5 | — |
| PRIMARY Physiological Responses as Measured by Blood Pressure After Lidocaine/Saline Administration. |
— | — |
| PRIMARY Physiological Responses as Measured by Galvanic Skin Response (GSR) After Lidocaine/Saline Administration. |
19.1; 20.1; 20.4 | — |
| PRIMARY Physiological Responses as Measured by EMG (Electromyography) After Lidocaine/Saline Administration. |
21.6; 28.1; 5.9 | — |
| SECONDARY Cocaine Use |
3.8; 2.7; 3.0 | — |
| SECONDARY Cocaine Craving |
32.3; 15.8; 20.9 | — |
Eligibility 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) (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.
Data sourced from ClinicalTrials.gov (NCT01929343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.