Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02275611
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2014-02-08
Brief Title:
Oxytocin Treatment of Alcohol Dependence
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Oxytocin Treatment of Alcohol Dependence A Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OT-ETOH2
Brief Summary:
This study will test in individuals who have alcohol dependence alcohol addiction the hypotheses 1 that intranasal oxytocin treatment will decrease withdrawal symptoms during medical detoxification and 2 that intranasal oxytocin treatment for 12 weeks in the outpatient setting will decrease drinking
Detailed Description:
Study Design This is a randomized double blind placebo-controlled early phase II clinical trial
Recruitment The study has 2 phases The first is testing intranasal treatments oxytocin OT placebo on alcohol withdrawal the inpatient phase and the second is testing intranasal treatments on alcohol drinking craving and anxiety over 12 weeks in the outpatient setting the outpatient phase Subjects for the inpatient phase will only be recruited from patients admitted to Freedom House FRH mental health center in Chapel Hill NC for medical detoxification from alcohol within the last 36 hours Subjects for the outpatient phase of the study will be inpatients at FRH or the University of North Carolina UNC Hospitals who are near the end of their inpatient stay medical detoxification has been or is nearly completed Subjects in the inpatient phase of the study at FRH may continue into the outpatient phase after discharge Subjects for the outpatient phase will also be heavy drinkers from the community who are screened during an initial outpatient clinic visit
Patients newly admitted to FRH to treat alcohol withdrawal will undergo a brief screening that includes 1 a recent and past alcohol use interview Time Line Follow Back TLFB and history of alcohol withdrawal interview 2 a brief psychiatric interview 3 a score on the 10-item CIWA scale of alcohol withdrawal symptoms 4 a review of potential medical exclusion criteria including a history of seizures or delirium tremens 5 a spot urine pregnancy test on all prospective female subjects
Recruitment into the outpatient phase treatment of outpatient drinking Patients who undergo medical detoxification from alcohol will be recruited from FRH or from UNC Hospitals toward the end of their admission for participation in a trial to test the efficacy of intranasal OT vs placebo treatment on alcohol drinking alcohol craving and anxiety during a 12-week outpatient treatment period They will be screened to see if they meet study criteria These individuals will read and sign the Breath Alcohol Policy that states that if their Breathalyzer reading at the beginning of an outpatient clinic visit is 08 they will not be assessed at that visit and will not drive themselves home but rather will accept a ride from a family member friend or a cab driver
Other individuals will be recruited from the community for participation in the outpatient phase of the study who have responded to a radio ad a UNC listserve ad a flyer have been referred by local clinicians or have otherwise become aware of the study These prospective subjects will undergo a telephone screening interview If they appear to meet criteria over the phone they will be further screened during an outpatient clinic visit They must sign the Breath Alcohol Policy
Inpatient Treatment of Withdrawal Protocol and Measures Subjects who enroll in the study shortly after being admitted to FRH will immediately complete the State portion of the Spielberger State-Trait Anxiety Inventory SSTAI and the Penn Alcohol Craving Scale PACS This will be followed by self-administration of their first intranasal test dose under supervision of research personnel These subjects will self-administer additional intranasal test doses at 1 and 3 h after the initial dose and then on the evening of that first day of admission On subsequent admission days at FRH subjects will self-administer intranasal test doses 3 times per day After the first intranasal test dose blood 15 ml and urine samples will be obtained from subjects at FRH by research personnel for complete blood count CBC electrolytes blood urea nitrogen BUN creatinine glucose albumin liver function tests urinalysis and urine toxicology which will be transported to and run at the UNC Hospital laboratory
Between the 1st and 3rd initial intranasal test doses research personnel will complete a more detailed psychiatric interview Subjects will also complete the University of Rhode Island Change Assessment Scale to assess their stage of motivation to stop or cut back on their drinking the Drinkers Inventory of Consequences to assess the spectrum of consequences related to drinking the Family History of Alcoholism Module to assess family history of alcohol problems the Patient Health Questionnaire PHQ to assess symptoms of depression and a Demographic Questionnaire During the first 2 inpatient days vital signs and CIWA scores will be obtained by FRH personnel every 4 hours or whenever subjects report or nurses observe the onset of withdrawal symptoms On the 3rd inpatient day these measures will be obtained 3 times And on subsequent inpatient days these measures will be obtained once each day and whenever withdrawal symptoms increase Subjects will complete the PACS and the SSTAI prior to administration of the 2nd test dose on each inpatient day starting the day after they enter the study Blood will be drawn early on inpatient day 3 for electrolyte measurements
In all subjects participating in the inpatient phase of the study lorazepam 2 mg a standard medication to decrease withdrawal symptoms will be administered by mouth PO whenever CIWA scores are 7 CIWA scores will be repeated 1 h after each lorazepam dose and another dose given if the CIWA score remains 7 Also lorazepam 2 mg will be administered if subjects are found to have any of the following elevated vital signs even if CIWA scores remain low pulse 110 diastolic blood pressure 100 systolic blood pressure 160 Vital signs as well as CIWA will be repeated 1 h after each lorazepam dose and another dose will be given if any of the elevated measures persist If a subjects CIWA score remains 7 pulse remains 110 or diastolic blood pressure remains 100 after 8 consecutive lorazepam doses systolic blood pressure remains 160 after 3 lorazepam doses or CIWA scores steadily increase despite receiving 3 consecutive lorazepam doses or dangerous symptoms develop eg the onset of hallucinations a more aggressive detoxification regimen will be initiated and the subject will be dropped from the study All patients admitted to FRH for alcohol detoxification receive thiamine folate and multivitamins supplementation
Initiating Outpatient Test Treatment Subjects recruited into the outpatient phase of the study at the end of an inpatient admission for medical detoxification from alcohol will be randomized to a treatment group and begin intranasal test treatment during their first outpatient clinic visit after discharge from FRH or UNC Hospitals Subjects recruited from the community will be randomized and begin intranasal test treatments at a outpatient clinic visit scheduled shortly after their screening clinic visit if assessments at the latter visit indicate they meet inclusion criteria and not exclusion criteria Several measures will be obtained at the beginning of the clinic visit when subjects begin self-administration of test treatments Breathalyzer reading CIWA rating TLFB interview assessment of recent alcohol consumption self-ratings on the SSTAI and PACS Research personnel will then instruct subjects in intranasal self-administration technique and then observe subjects take their first intranasal test dose Subjects will be given written instructions on intranasal self-administration technique cleaning the spray bottle nozzle after each dose storing spray bottles between doses and contacting study personnel if they have question difficulty with the self-administration procedure or may be experiencing side effects At the end of the clinic visit subjects will take home a 60 ml spray bottle that ejects 01 ml metered dose per insufflation containing 25 ml of test solution which they will use to self-administer test treatment doses twice daily 6 insufflationsdose
Outpatient clinic visits during the treatment period Subjects will have follow-up outpatient clinic visits at weeks 1 2 3 4 6 8 10 and 12 after starting intranasal test treatments Outpatient visits will take place in the Psychiatry Clinics in the UNC Neurosciences Hospital or the Alcohol and Substance Abuse Program ASAP clinic which is located off of the UNC campus on a bus line making it more convenient for participants to commute and park thereby facilitating their compliance with the outpatient portion of the study To enhance continuity the first visit will be 2-3 days after the clinic visit during which intranasal test treatments are started At each clinic visit a Breathalyzer reading a CIWA score and vital signs will be obtained a TLFB interview administered to quantify daily alcohol intake since the last clinic visit and the SSTAI PACS and PHQ questionnaires will be completed Subjects will be given a fresh 60 ml intranasal spray bottle containing 25 ml of test substance at clinic visits every 2 weeks At each clinic visit subjects spray bottles will be weighed to monitor compliance Their intranasal self-administration technique will be reviewed and if necessary subjects will be reinstructed in proper technique At 4 8 and 12 weeks blood will be drawn for CBC liver functions electrolytes BUN creatinine and a urine sample will be obtained for drug screening and pregnancy tests on all female subjects
During each clinic visit 15 minutes of substance use counseling Medical Management will be provided
Recruitment The study has 2 phases The first is testing intranasal treatments oxytocin OT placebo on alcohol withdrawal the inpatient phase and the second is testing intranasal treatments on alcohol drinking craving and anxiety over 12 weeks in the outpatient setting the outpatient phase Subjects for the inpatient phase will only be recruited from patients admitted to Freedom House FRH mental health center in Chapel Hill NC for medical detoxification from alcohol within the last 36 hours Subjects for the outpatient phase of the study will be inpatients at FRH or the University of North Carolina UNC Hospitals who are near the end of their inpatient stay medical detoxification has been or is nearly completed Subjects in the inpatient phase of the study at FRH may continue into the outpatient phase after discharge Subjects for the outpatient phase will also be heavy drinkers from the community who are screened during an initial outpatient clinic visit
Patients newly admitted to FRH to treat alcohol withdrawal will undergo a brief screening that includes 1 a recent and past alcohol use interview Time Line Follow Back TLFB and history of alcohol withdrawal interview 2 a brief psychiatric interview 3 a score on the 10-item CIWA scale of alcohol withdrawal symptoms 4 a review of potential medical exclusion criteria including a history of seizures or delirium tremens 5 a spot urine pregnancy test on all prospective female subjects
Recruitment into the outpatient phase treatment of outpatient drinking Patients who undergo medical detoxification from alcohol will be recruited from FRH or from UNC Hospitals toward the end of their admission for participation in a trial to test the efficacy of intranasal OT vs placebo treatment on alcohol drinking alcohol craving and anxiety during a 12-week outpatient treatment period They will be screened to see if they meet study criteria These individuals will read and sign the Breath Alcohol Policy that states that if their Breathalyzer reading at the beginning of an outpatient clinic visit is 08 they will not be assessed at that visit and will not drive themselves home but rather will accept a ride from a family member friend or a cab driver
Other individuals will be recruited from the community for participation in the outpatient phase of the study who have responded to a radio ad a UNC listserve ad a flyer have been referred by local clinicians or have otherwise become aware of the study These prospective subjects will undergo a telephone screening interview If they appear to meet criteria over the phone they will be further screened during an outpatient clinic visit They must sign the Breath Alcohol Policy
Inpatient Treatment of Withdrawal Protocol and Measures Subjects who enroll in the study shortly after being admitted to FRH will immediately complete the State portion of the Spielberger State-Trait Anxiety Inventory SSTAI and the Penn Alcohol Craving Scale PACS This will be followed by self-administration of their first intranasal test dose under supervision of research personnel These subjects will self-administer additional intranasal test doses at 1 and 3 h after the initial dose and then on the evening of that first day of admission On subsequent admission days at FRH subjects will self-administer intranasal test doses 3 times per day After the first intranasal test dose blood 15 ml and urine samples will be obtained from subjects at FRH by research personnel for complete blood count CBC electrolytes blood urea nitrogen BUN creatinine glucose albumin liver function tests urinalysis and urine toxicology which will be transported to and run at the UNC Hospital laboratory
Between the 1st and 3rd initial intranasal test doses research personnel will complete a more detailed psychiatric interview Subjects will also complete the University of Rhode Island Change Assessment Scale to assess their stage of motivation to stop or cut back on their drinking the Drinkers Inventory of Consequences to assess the spectrum of consequences related to drinking the Family History of Alcoholism Module to assess family history of alcohol problems the Patient Health Questionnaire PHQ to assess symptoms of depression and a Demographic Questionnaire During the first 2 inpatient days vital signs and CIWA scores will be obtained by FRH personnel every 4 hours or whenever subjects report or nurses observe the onset of withdrawal symptoms On the 3rd inpatient day these measures will be obtained 3 times And on subsequent inpatient days these measures will be obtained once each day and whenever withdrawal symptoms increase Subjects will complete the PACS and the SSTAI prior to administration of the 2nd test dose on each inpatient day starting the day after they enter the study Blood will be drawn early on inpatient day 3 for electrolyte measurements
In all subjects participating in the inpatient phase of the study lorazepam 2 mg a standard medication to decrease withdrawal symptoms will be administered by mouth PO whenever CIWA scores are 7 CIWA scores will be repeated 1 h after each lorazepam dose and another dose given if the CIWA score remains 7 Also lorazepam 2 mg will be administered if subjects are found to have any of the following elevated vital signs even if CIWA scores remain low pulse 110 diastolic blood pressure 100 systolic blood pressure 160 Vital signs as well as CIWA will be repeated 1 h after each lorazepam dose and another dose will be given if any of the elevated measures persist If a subjects CIWA score remains 7 pulse remains 110 or diastolic blood pressure remains 100 after 8 consecutive lorazepam doses systolic blood pressure remains 160 after 3 lorazepam doses or CIWA scores steadily increase despite receiving 3 consecutive lorazepam doses or dangerous symptoms develop eg the onset of hallucinations a more aggressive detoxification regimen will be initiated and the subject will be dropped from the study All patients admitted to FRH for alcohol detoxification receive thiamine folate and multivitamins supplementation
Initiating Outpatient Test Treatment Subjects recruited into the outpatient phase of the study at the end of an inpatient admission for medical detoxification from alcohol will be randomized to a treatment group and begin intranasal test treatment during their first outpatient clinic visit after discharge from FRH or UNC Hospitals Subjects recruited from the community will be randomized and begin intranasal test treatments at a outpatient clinic visit scheduled shortly after their screening clinic visit if assessments at the latter visit indicate they meet inclusion criteria and not exclusion criteria Several measures will be obtained at the beginning of the clinic visit when subjects begin self-administration of test treatments Breathalyzer reading CIWA rating TLFB interview assessment of recent alcohol consumption self-ratings on the SSTAI and PACS Research personnel will then instruct subjects in intranasal self-administration technique and then observe subjects take their first intranasal test dose Subjects will be given written instructions on intranasal self-administration technique cleaning the spray bottle nozzle after each dose storing spray bottles between doses and contacting study personnel if they have question difficulty with the self-administration procedure or may be experiencing side effects At the end of the clinic visit subjects will take home a 60 ml spray bottle that ejects 01 ml metered dose per insufflation containing 25 ml of test solution which they will use to self-administer test treatment doses twice daily 6 insufflationsdose
Outpatient clinic visits during the treatment period Subjects will have follow-up outpatient clinic visits at weeks 1 2 3 4 6 8 10 and 12 after starting intranasal test treatments Outpatient visits will take place in the Psychiatry Clinics in the UNC Neurosciences Hospital or the Alcohol and Substance Abuse Program ASAP clinic which is located off of the UNC campus on a bus line making it more convenient for participants to commute and park thereby facilitating their compliance with the outpatient portion of the study To enhance continuity the first visit will be 2-3 days after the clinic visit during which intranasal test treatments are started At each clinic visit a Breathalyzer reading a CIWA score and vital signs will be obtained a TLFB interview administered to quantify daily alcohol intake since the last clinic visit and the SSTAI PACS and PHQ questionnaires will be completed Subjects will be given a fresh 60 ml intranasal spray bottle containing 25 ml of test substance at clinic visits every 2 weeks At each clinic visit subjects spray bottles will be weighed to monitor compliance Their intranasal self-administration technique will be reviewed and if necessary subjects will be reinstructed in proper technique At 4 8 and 12 weeks blood will be drawn for CBC liver functions electrolytes BUN creatinine and a urine sample will be obtained for drug screening and pregnancy tests on all female subjects
During each clinic visit 15 minutes of substance use counseling Medical Management will be provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None