Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | January 2015 |
| End Date: | February 2016 |
| Contact: | Elias Dakwar, MD |
| Email: | dakware@nyspi.columbia.edu |
| Phone: | (646) 774-8728 |
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 with CI-581 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).
It has also demonstrated rapid and robust increases in motivation to change drug use and
decreases in craving elicited by drug cues. These benefits may persist for at least 72 hours
after a single infusion. 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. Opioid dependent individuals will
undergo a rapid naltrexone initiation procedure after being administered an infusion of an
NMDA antagonist over 92 minutes. After administration of extended-release naltrexone,
participants will be followed for 4 weeks, and transitioned to appropriate care subsequently
(oral naltrexone, extended-release naltrexone).
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 with CI-581 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).
It has also demonstrated rapid and robust increases in motivation to change drug use and
decreases in craving elicited by drug cues. These benefits may persist for at least 72 hours
after a single infusion. 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. Opioid dependent individuals will
undergo a rapid naltrexone initiation procedure after being administered an infusion of an
NMDA antagonist over 92 minutes. After administration of extended-release naltrexone,
participants will be followed for 4 weeks, and transitioned to appropriate care subsequently
(oral naltrexone, extended-release naltrexone).
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
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