Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence

NCT ID: NCT02437344

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

Brief Summary

Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal.

N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal.

The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).

Conditions

Opioid Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CI-581aa

CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing

Group Type: EXPERIMENTAL

CI-581aa

Intervention Type: DRUG

92 minute infusion of CI-581aa

Naltrexone titration and XR-NTX initiation

Intervention Type: DRUG

participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Interventions

CI-581aa

92 minute infusion of CI-581aa

Intervention Type: DRUG

Naltrexone titration and XR-NTX initiation

participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Intervention Type: DRUG

Other Intervention Names

NMDA antagonist; naltrexone

Eligibility Criteria

Inclusion Criteria

1. Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine

2. Physically healthy

3. No adverse reactions to study medications

4. 21-60 years of age

5. Capacity to consent and comply with study procedures

6. Seeking treatment

Exclusion Criteria

1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder with HAMD > 12.

2. Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis

3. Pregnant or interested in becoming pregnant

4. Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders

5. Current suicide risk or a history of suicide attempt within the past 2 years

6. On psychotropic or other medication whose effect could be disrupted by participation in the study

7. Recent history of significant violence (past 2 years).

8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.

9. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease (transaminase levels < 2 X the upper limit of normal will be considered acceptable), or untreated diabetes

10. Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines

11. BMI > 35, or a history of unmanaged obstructive sleep apnea

12. First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)

13. History of opioid overdose over the past 2 years requiring medical intervention

14. Currently using methadone or buprenorphine

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Elias Dakwar

Assistant Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elias Dakwar, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

#7057

Identifier Type: -

Identifier Source: org_study_id