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Completed

NCT Number: NCT02437344

Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence

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).

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine
  • Physically healthy
  • No adverse reactions to study medications
  • 21-60 years of age
  • Capacity to consent and comply with study procedures
  • Seeking treatment

Exclusion criteria

  • 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.
  • Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis
  • Pregnant or interested in becoming pregnant
  • Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
  • Current suicide risk or a history of suicide attempt within the past 2 years
  • On psychotropic or other medication whose effect could be disrupted by participation in the study
  • Recent history of significant violence (past 2 years).
  • Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
  • 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
  • Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines
  • BMI > 35, or a history of unmanaged obstructive sleep apnea
  • First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
  • History of opioid overdose over the past 2 years requiring medical intervention
  • Currently using methadone or buprenorphine

Treatment and study plan

CI-581aa

Drug

92 minute infusion of CI-581aa

Other names: NMDA antagonist

Naltrexone titration and XR-NTX initiation

Drug

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

Other names: naltrexone

Primary outcomes

  1. Successful Naltrexone Initiation

    Time frame: 2 weeks

    The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX

Secondary outcomes

  1. Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently

    Time frame: 4 days

    Subjective Opioid Withdrawal Scale (SOWS) is a scale out of 64 points assessing withdrawal severity that is administered serially, every several hours, over the course of the naltrexone initiation. The questionnaire assesses symptoms that the patient rates on a scale of 0 (not at all) to 4 (extremely). The difference in total (sum) scores between baseline and end-of-induction will be reported. Scores range from 0 to 64.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 7, 2015
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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