ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

• Sponsor: Alkermes, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00834080
• Collaborator: (none)
• Enrollment: 38
• Locations: 11
• Arm: 1
• Duration (Months): 38
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Drug: Medisorb naltrexone 380 mg	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medisorb naltrexone 380 mg (VIVITROL)	Drug: Medisorb naltrexone 380 mg; Intramuscular (IM) injection administered once every 4 weeks for up to 2 years; Other Names: VIVITROL 380 mg Naltrexone for extended-release injectable suspension

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [2 years (Baseline to end of study)]

   A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Primary Inclusion Criteria:

• Health care professional (eg, physician, osteopath, nurse, pharmacist)

• 18 years of age or older

• Enrolled or enrolling in an extended outpatient treatment program for opioid dependence

• Women of childbearing potential must agree to use an approved method of contraception for the duration of the study

Primary Exclusion Criteria:

• Pregnancy and/or lactation

• Evidence of hepatic failure

• Active hepatitis

• Any psychiatric disorder that would compromise ability to complete study requirements

• Recent history of suicidal ideation or attempt

• Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine

• Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alkermes Clinical Study Site	Colton	California	United States	92324
2	Alkermes Clinical Study Site	Oceanside	California	United States	92056
3	Alkermes Clinical Study Site	Lauderhill	Florida	United States	33319
4	Alkermes Clinical Study Site	Hoffman Estates	Illinois	United States	60194
5	Alkermes Clinical Study Site	Saint Louis	Missouri	United States	63109
6	Alkermes Clinical Study Site	Elmsford	New York	United States	10523
7	Alkermes Clinical Study Site	Canton	Ohio	United States	44718
8	Alkermes Clinical Study Site	Philadelphia	Pennsylvania	United States	19118
9	Alkermes Clinical Study Site	Philadelphia	Pennsylvania	United States	19125
10	Alkermes Clinical Study Site	Austin	Texas	United States	78754
11	Alkermes Clinical Study Site	Dallas	Texas	United States	75225

Sponsors and Collaborators

• Alkermes, Inc.

Investigators

• Study Director: Alkermes Medical Director, Alkermes, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alkermes, Inc.
• ClinicalTrials.gov Identifier: NCT00834080
• Other Study ID Numbers: ALK21-021
• First Posted: Feb 3, 2009
• Last Update Posted: Dec 11, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Alkermes, Inc.: opioid dependence; VIVITROL; opioid-related disorders
• Additional relevant MeSH terms: Opioid-Related Disorders; Naltrexone

Study Results

Participant Flow

Recruitment Details	This study had a 12 month recruitment period (May 2009 through April 2010). A total of 11 sites in the United States participated. Principal Investigators were addiction specialists who had contact with health care professionals in need of treatment for opioid dependence.
Pre-assignment Detail	Potential subjects must have participated in a detoxification program for opioid dependence. Subjects participated in psychosocial treatment throughout their study participation.

Arm/Group Title	VIVITROL
Arm/Group Description	Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
Period Title: Overall Study
STARTED	38
COMPLETED	15
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	VIVITROL, 380mg
Arm/Group Description
Overall Participants	38
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	38 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.4 (10.39)
Sex: Female, Male (Count of Participants)
Female	31 81.6%
Male	7 18.4%
Region of Enrollment (participants) [Number]
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
Description	A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Time Frame	2 years (Baseline to end of study)

Outcome Measure Data

Analysis Population Description

The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.

Arm/Group Title	VIVITROL
Arm/Group Description	Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
Measure Participants	38
Number [participants]	37 97.4%

Adverse Events

Arm/Group Title	Medisorb Naltrexone 380 mg (VIVITROL)
Arm/Group Description	Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
All Cause Mortality
	Medisorb Naltrexone 380 mg (VIVITROL)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Medisorb Naltrexone 380 mg (VIVITROL)
	Affected / at Risk (%)	# Events
Total	2/38 (5.3%)
Injury, poisoning and procedural complications
Head Injury	1/38 (2.6%)	1
Psychiatric disorders
Suicide Attempt	1/38 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Medisorb Naltrexone 380 mg (VIVITROL)
	Affected / at Risk (%)	# Events
Total	37/38 (97.4%)
Gastrointestinal disorders
Nausea	16/38 (42.1%)	37
Diarrhoea	5/38 (13.2%)	11
Vomiting	5/38 (13.2%)	7
Toothache	3/38 (7.9%)	6
Abdominal discomfort	2/38 (5.3%)	6
Abdominal pain upper	2/38 (5.3%)	2
Constipation	2/38 (5.3%)	3
Dyspepsia	2/38 (5.3%)	2
General disorders
Injection site pain	14/38 (36.8%)	25
Fatigue	4/38 (10.5%)	4
Injection site induration	3/38 (7.9%)	5
Injection site mass	3/38 (7.9%)	6
Injection site nodule	3/38 (7.9%)	3
Irritability	3/38 (7.9%)	3
Chest pain	2/38 (5.3%)	2
Discomfort	2/38 (5.3%)	3
Oedema peripheral	2/38 (5.3%)	3
Pyrexia	2/38 (5.3%)	2
Immune system disorders
Seasonal allergy	2/38 (5.3%)	2
Infections and infestations
Upper respiratory tract infection	8/38 (21.1%)	9
Bronchitis	5/38 (13.2%)	6
Sinusitis	5/38 (13.2%)	6
Tooth abscess	3/38 (7.9%)	5
Urinary tract infection	3/38 (7.9%)	3
Influenza	2/38 (5.3%)	3
Injury, poisoning and procedural complications
Contusion	3/38 (7.9%)	6
Joint dislocation	2/38 (5.3%)	2
Muscle strain	2/38 (5.3%)	2
Metabolism and nutrition disorders
Decreased appetite	4/38 (10.5%)	8
Increased appetite	2/38 (5.3%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	7/38 (18.4%)	8
Back pain	2/38 (5.3%)	2
Myalgia	2/38 (5.3%)	2
Nervous system disorders
Headache	10/38 (26.3%)	12
Dizziness	6/38 (15.8%)	6
Amnesia	2/38 (5.3%)	2
Disturbance in attention	2/38 (5.3%)	2
Psychiatric disorders
Anxiety	11/38 (28.9%)	16
Depression	5/38 (13.2%)	5
Insomnia	3/38 (7.9%)	5
Attention deficit/hyperactivity disorder	2/38 (5.3%)	2
Skin and subcutaneous tissue disorders
Alopecia	3/38 (7.9%)	3
Rash	2/38 (5.3%)	2
Vascular disorders
Hypertension	2/38 (5.3%)	2

Limitations/Caveats

After screening 49 subjects, Alkermes made a business decision to stop enrollment, resulting in 38 total subjects enrolled.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A copy of such disclosure must be given to Alkermes for review at least sixty (60) days prior to submission for publication, presentation or delivery to any other party. Revisions to such disclosure will be negotiated in good faith by the Institution, Principal Investigator and Alkermes. Expedited reviews for abstracts or poster presentations may be arranged if mutually agreeable to Alkermes and the Institution.