Phase 2 Completed N=20 Randomized Triple-blind Treatment

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

Cocaine Use Disorder · Anxiety

Source: ClinicalTrials.gov NCT02785406 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcomePrimary: Cue Reactivity as Assessed by the Attention Bias (AB) Task — 0.524; 0.519 score on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cue Reactivity as Assessed by the Attention Bias (AB) Task	0.488; 0.508	—
PRIMARY Cue Reactivity as Assessed by the Attention Bias (AB) Task	0.488; 0.508	—
PRIMARY Cue Reactivity as Assessed by the Attention Bias (AB) Task	0.488; 0.508	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Total Sleep as Assessed by the Misfit Shine Device	6.57; 7.56	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale	2.8; 2.3	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale.	2.6; 2.3	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale	1.4; 0.8	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale	1.4; 0.8	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale	1.4; 0.8	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale	1.4; 0.8	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale	1.4; 0.8	—
PRIMARY Anxiety as Assessed by the DASS21 Self-report Questionnaire	2.2; 1.1	—
SECONDARY Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief	3.61; 2.7; 3.01; 2.8; 2.92; 2.48	—
SECONDARY Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI)	7.5; 7; 9.38; 6.6; 8.2; 4.89	—
SECONDARY Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Systolic Blood Pressure	125; 120; 126; 125; 128; 121	—
SECONDARY Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure	84.6; 80.7; 84.8; 83.6; 85.4; 81.1	—
SECONDARY Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT)	553; 1269; 1108; 957; 532; 629	—
SECONDARY Stress as Assessed by a Visual Analog Scale (VAS) for Stress	192; 138; 168; 127; 151; 124	—
SECONDARY Percent Medication Compliance as Assessed by the Medical Event Monitoring System (MEMS, Aprex Corporation) Bottles	91.9; 100; 81.8; 100; 81.8; 100	—
SECONDARY Percent Medication Compliance as Assessed by Pill Counts	95.5; 100; 95; 100; 100; 100	—
SECONDARY Percent Medication Compliance as Assessed by Analysis of Riboflavin Markers in Urine Samples	100; 100; 100; 89; 100; 100	—
SECONDARY Percent Medication Compliance as Assessed by Text Reminders and Replies	55.6; 100; 55.6; 87.5; 70; 100	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02785406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.