Oxytocin Treatment of Alcohol Withdrawal
|ClinicalTrials.gov Identifier: NCT01212185|
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring standard medication treatment (lorazepam) and the amount of lorazepam required to control withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of subject recruitment and retention in the inpatient setting.
Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical detoxification.
Procedures (methods): Subjects will be inpatients undergoing medical detoxification from alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a randomized, double blind manner for three days. Withdrawal symptoms will be measured routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever withdrawal symptoms increase above specific parameters.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Withdrawal||Drug: intranasal oxytocin spray Other: intranasal spray without oxytocin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Oxytocin Treatment of Alcohol Withdrawal|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Placebo Comparator: intranasal spray without oxytocin
Twice daily intranasal spray without oxytocin.
Other: intranasal spray without oxytocin
6 insufflations (0.1 metered dose/insufflation) twice daily
Experimental: intranasal oxytocin spray
Twice daily intranasal oxytocin spray
Drug: intranasal oxytocin spray
6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
Other Name: Syntocinon Spray
- Total Lorazepam Dosage (in Milligrams) [ Time Frame: Days 1 to 5 ]Total lorazepam (in milligrams) required per subject to complete detoxification
- CIWA-Ar Scores [ Time Frame: days 1 ]Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212185
|United States, North Carolina|
|University of North Carolina Hospitals|
|Chapel Hill, North Carolina, United States, 27599|
|Central Regional Hospital|
|Raleigh, North Carolina, United States, 27603|
|Principal Investigator:||Cort A Pedersen, M.D.||The University of North Carolina, Chapel Hill, Department of Psychiatry|