Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder (SEARCH)
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|ClinicalTrials.gov Identifier: NCT04169360|
Recruitment Status : Withdrawn (The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences, the product company of ANS-6637, is no longer pursuing research with this compound.)
First Posted : November 19, 2019
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Drug: ANS-6637 Drug: Placebo oral tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder|
|Estimated Study Start Date :||January 2021|
|Actual Primary Completion Date :||January 12, 2021|
|Actual Study Completion Date :||January 12, 2021|
ANS-6637 600mg once daily for 12 weeks
White, oblong 300 mg tablet
Placebo Comparator: Placebo arm
Placebo 600 mg once daily for 12 weeks
Drug: Placebo oral tablet
White, oblong 300 mg tablet
- Number of Grade 3-4 events, Grade 2 Significant event [ Time Frame: 16 weeks ]The number of Grade 3-4 adverse events, as defined by the Division of AIDS (DAIDS) Toxicity Table Version 2.1, July, 2017 as well as the number of Grade 2 events requiring medication interruption or deemed clinically significant by a study investigator
- Urine Drug Screen [ Time Frame: 16 weeks ]Percentage opioid free period by urine drug screen
- Opioid Craving [ Time Frame: 16 weeks ]Opioid craving will be assessed using the Opioid Craving scale questionnaire. The questionnaire consists of three questions and each of these questions has a minimum value of 0 and a maximum value 10. A score of 0 on each question is the best outcome; a score of 10 on each question is the worst outcome.
- Opioid Agonist Therapy (OAT) concentration [ Time Frame: 16 weeks ]Serum concentration of buprenorphine or methadone
- Self reported description of drug use (Self-reported frequency/quantity/mode of opioid use, self-reported use of other drugs, overdose and overdose death) [ Time Frame: 16 weeks ]Self-reported frequency/quantity/mode of opioid use as well as self-reported use of other drugs will be gathered using the Drug Use Survey. Subjects will indicate frequency of opioid use by documenting the number of times they used an opioid during a given day. The quantity of opioids used will be determined by the dollar amount of opioids the subject reports they have consumed during that day. Subjects will also report mode of opioid use by indicating whether they are using opioids via injection, skin popping, snorting or oral. The Drug Use Survey will also ask subjects to report incidence of use of non-opioid substances. Incidence of overdose will be captured with the Naloxone questionnaire which asks, "since you last visit, have you experienced an overdose?". Incidence of overdose death will measured by the number of medical examiner confirmed deaths of study participants with cause of death listed as "overdose related to an opioid".
- Change in Darke HIV Risk Taking Behavior Survey Score [ Time Frame: 16 weeks ]The Darke HIV Risk Taking Behavior Questionnaire will be administered to assess subject's self-reported risk taking behaviors. Total scores on the test range from 0 to 55, with higher scores indicating a greater degree of risk-taking behavior.
- Change in HIV Test Result [ Time Frame: 16 weeks ]An HIV test (fourth generation antigen/antibody test) will be administered and the results are reported as either positive or negative.
- Change in Hepatitis C (HCV) RNA result [ Time Frame: 16 weeks ]A Hepatitis C (HCV) RNA test will be administered. This test measures the quantity of detectable RNA which is measured in IU/ml.
- Change in appetite [ Time Frame: 16 weeks ]Self reported changes in appetite will be captured by the Adverse Event Survey. The survey will ask, "since your last visit, have you had an increase in your appetite or a decrease in your appetite?".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169360
|Principal Investigator:||Sarah Kattakuzhy, MD||Institute of Human Virology at the University of Maryland|