Oxytocin and Alcohol Withdrawal and Dependence

NCT ID: NCT02903251

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-01-22

Brief Summary

This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.

Conditions

Alcoholism; Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oxytocin

intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel.

Day 3-30: Self-administered intranasal spray as needed, max thrice daily intranasal spray without oxytocin

Group Type: EXPERIMENTAL

intranasal oxytocin spray

Intervention Type: DRUG

6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30.

Placebo

intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel.

Day 3-30: Self-administered intranasal spray as needed, max thrice daily

Group Type: PLACEBO_COMPARATOR

intranasal spray without oxytocin

Intervention Type: OTHER

6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30.

Interventions

intranasal oxytocin spray

6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30.

Intervention Type: DRUG

intranasal spray without oxytocin

6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30.

Intervention Type: OTHER

Other Intervention Names

Syntocinon; placebo

Eligibility Criteria

Inclusion Criteria

1. At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption

2. average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;

3. consenting to participate in the study;

4. have residency in Trøndelag County after discharge

Exclusion Criteria

1. chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;

2. dependence on substances other than alcohol, nicotine or caffeine;

3. inadequately treated, unstable and/or compromising medical or psychiatric conditions;

4. low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years;

5. pregnancy; parturition or breast-feeding in the past 6 months;

6. inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;

7. no alcohol in the blood and > 15 h since last intake of alcohol;

8. prior inclusion and participation in the same study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Lade Addiction Treatment Center

UNKNOWN

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trond Jacobsen, MD PhD

Role: STUDY_DIRECTOR

St Olav's University Hospital Trondheim

Olav Spigset, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Lade Addiction Treatment Center

Trondheim, , Norway

Countries

Norway

References

Melby K, Grawe RW, Aamo TO, Salvesen O, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Apr 1;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.003. Epub 2019 Feb 13.

Reference Type: RESULT

PMID: 30784955 (View on PubMed)

Other Identifiers

2015-004463-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

140682

Identifier Type: -

Identifier Source: org_study_id