Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Cocaine Use Disorder

Anxiety

Treatments

Drug: Placebo (for suvorexant)

Drug: suvorexant

Study type

Interventional

Funder types

Other

Identifiers

NCT02785406

HSC-MS-16-0120

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of a medication called suvorexant in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.

Full description

Preclinical research has established important functions for the orexin system in mediating arousal/sleep, stress, and cue-induced reinstatement of drug taking (e.g., relapse). The role of stress/anxiety and drug cue reactivity in human drug relapse is well established, but to date, the role of the orexin system in modulating these phenomena has not been examined in humans with substance use disorders (e.g., cocaine). The goal of the present first-in-human study will be to examine the effects of an orexin antagonist (suvorexant) on interactions among stress/anxiety, sleep, and drug-cue reactivity. The study will utilize a battery of highly sensitive, drug-specific, laboratory measures of drug cue reactivity (a relapse risk model), and well-established metrics of stress/anxiety and sleep. The hypothesis is that antagonism of the orexin system will attenuate the link between (1) stress/anxiety and drug cue reactivity, and (2) sleep and drug cue reactivity. These results will elucidate a unique biochemical mechanism for understanding relapse, and provide a potential medication target for relapse prevention.

Enrollment

20 patients

Sex

All

Ages

19 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

meet current DSM-5 criteria for cocaine use disorder (CUD) of at least moderate severity (≥4 symptoms)

Exclusion criteria

current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
significant current suicidal or homicidal ideation
medical conditions contraindicating administration of suvorexant (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
taking medications known to have significant drug interactions with the study medication(s) (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and all sedatives)
currently or recently (last 3 months) treated for substance use [other than cocaine or nicotine] or another psychiatric condition
conditions of probation or parole requiring reports of drug use to officers of the court; (8) impending incarceration
pregnant or nursing for female patients
inability to read, write, or speak English [required for lab tasks and psychometric scales]
unwillingness to sign a written informed consent form
subjects with alcohol use disorders or are drinking > 7 alcoholic drinks per week. All subjects who are excluded will be given referral information to other local treatment programs.