A Study to Evaluate Heart Rate Variability in Alcohol-dependent Subjects in Treatment

Overview

About this study

Alcohol abuse and dependence remain highly prevalent and disabling. Persistent low treatment rates and high relapse rates indicate the need for more research in treatment of alcoholism. It is well known that craving is a core component of alcohol dependence associated with relapse. Unfortunately current methods of assessment of craving intensity are based on the subjective response to questionnaires. Identification of the physiological correlates of craving intensity holds promise for improving our understanding and prediction of which patients will be at higher risk of relapse. Number of studies showed that cue induced craving for alcohol was associated with changes in length of the heart inter-beat intervals also called heart rate variability (HRV). HRV can be easily and noninvasively monitored and analysis of its indices provides means of understanding the interplay between autonomic and cardiovascular functional regulation. We hypothesize that alcohol dependent subjects will demonstrate increased HRV indices after treatment, compared to HRV indices at time of admission.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female patients of 18 years or older.
  • Provides written informed consent.
  • DSM-IV diagnosis of alcohol dependence.
  • No alcohol consumption for at least 3 days before enrollment.
  • No signs of alcohol withdrawal as per CIWA protocol assessment.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Negative research status (opting out of research using personal medical records)
  • Diagnoses of a major psychiatric disorder of a psychotic nature such as: schizophrenia, bipolar disorder, schizoaffective disorder, delusional disorder or psychotic disorder NOS.
  • Active addiction or prescription use of barbiturates, benzodiazepines, opiates, hallucinogens, stimulants and/or cocaine at the time when patient developed withdrawal seizure and/or DT.
  • Presence of signs and/or symptoms of alcohol withdrawal (CIWA protocol > 5 with TREMOR rating of 3 and above).
  • ECG showing conduction delay or premature atrial or ventricular contractions.
  • History of cardiac illness including coronary artery disease, congestive heart failure, arrhythmia (in particular A-V blocks, significant bradycardia, atrial fibrillation, supraventricular tachycardia, or ventricular fibrillation or tachycardia).
  • History of diabetic neuropathy.
  • Status post heart transplant, bypass surgery or with implantable cardioverter defibrillator or pacemaker.
  • Prescription use of medications known to alter heart rate, such as tricyclic antidepressants or beta-blockers.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Magdalena Romanowicz, M.D.

Closed for enrollment

Contact information:

Magdalena Romanowicz M.D.

(507) 255-9035

Romanowicz.Magdalena@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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CLS-20506880

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