Risks and Benefits of Naloxone Prescribing

NCT02535494 | Completed

• 2 other identifiers: 6723R01DA035207
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is one of the first large-scale, prospective attempts to obtain data on the effectiveness of naloxone distribution among opioid-abusing populations at high risk of unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug detoxification sites as well as those accessing services at needle exchange programs. All participants (N=700) will receive the standard opioid overdose education and naloxone. One third of the participants will be randomized to receive additional in-depth psychosocial education focusing on recognition and prevention of opioid overdose, and appropriate use of naloxone. Another third of the participants will receive the extensive training and be required to engage a spouse, partner, relative, or friend in this supplementary intervention. The investigators plan to randomize individuals to each group \[Treatment as Usual (TAU) vs. Extensively Trained (ET) vs. Extensively Trained with a Significant Other (ETwSO)\] and, through continued follow up over one year, the investigators will compare self-reported overdose reversal attempts (with and without naloxone use), naloxone-related adverse events, and changes in patterns of heroin and other drug use.

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (2)

• Likelihood of Naloxone Use

  Determine the extent to which additional psychosocial intervention can improve upon the effectiveness of current overdose prevention training by increasing the frequency of naloxone use

  1 year

• Overdose Reversal Outcome

  Determine the extent to which additional psychosocial intervention can improve the ability of the training to decrease the number of lethal opioid overdoses.

  1 year

Study Arms (3)

Standard Training

NO INTERVENTION

Participants receive our standard overdose training.

Extensive Training

EXPERIMENTAL

Participant receives an more in-depth, extensive training concerning opioid overdose.

Other: Extensive training

Extensive Training w/ Significant Other

EXPERIMENTAL

Participant and their significant other both receive a more in-depth, extensive training concerning opioid overdose.

Other: Extensive training

Interventions

Extensive training OTHER

We have developed a more in-depth education package to help participants better recognize and respond to an opioid overdose.

Extensive Training; Extensive Training w/ Significant Other

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 21 to 65 years
• Has met DSM-V criteria for moderate-severe opioid use disorder within the past 6-months, actively using heroin, prescription opioids, or has detoxified within the last 3 months.
• In otherwise good health based on medical history and laboratory tests
• Able to provide informed consent and comply with study procedures
• Able to fluently speak and read English
• Able to identify a spouse, friend or relative who willing to serve as their "significant other"

You may not qualify if:

• Active psychiatric disorder that might interfere with participation or make participation hazardous, including DSM-V organic mental disorder, psychotic disorder, or bipolar disorder with mania
• Previous Basic Cardiac Life Support or First-Aid training
• Active treatment with extended-release naltrexone (Vivitrol) for alcohol or opioid dependence
• Naloxone training for opioid overdose prevention in the previous 2 years (Clinical Interview)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Indivior Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Jones JD, Campbell AN, Brandt L, Metz VE, Martinez S, Wall M, Corbeil T, Andrews H, Castillo F, Neale J, Strang J, Ross S, Comer SD. A randomized clinical trial of the effects of brief versus extended opioid overdose education on naloxone utilization outcomes by individuals with opioid use disorder. Drug Alcohol Depend. 2022 Aug 1;237:109505. doi: 10.1016/j.drugalcdep.2022.109505. Epub 2022 May 23.

  PMID: 35709575 DERIVED

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Sandra D Comer, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Neurobiology

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)