Alcohol Use Disorder Clinical Trial
— EDITOROfficial title:
Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | June 30, 2025 |
| Est. primary completion date | March 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: 1. Age 18 - 80 years, inclusive at enrollment. 2. Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month. 3. Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis 4. Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study 5. Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception 6. Willing to sign the informed consent form. 7. Have a stable place to stay and retain the EDITOR devices in a secure condition when receiving the intervention and during the entire duration of the study participation. Exclusion Criteria: 1. Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures. 2. Mental retardation. 3. Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment. 4. Experiencing current suicide ideas or plans. 5. Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI. 6. History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI. 7. Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon. 8. Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment. 9. Individuals who are on parole or probation. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Maryland Treatment Center | Rockville | Maryland |
| United States | Clinics of Dr. Edwin Chapman @ MHDG | Washington | District of Columbia |
| United States | Howard University | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Evon Medics LLC | Clinics of Dr. Edwin Chapman, MD, PC @ MHDG, Howard University, Maryland Treatment Center, National Institute on Drug Abuse (NIDA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Retention in SUD treatment | 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit. |
Baseline to day 14 | |
| Primary | Retention in SUD treatment | 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit. |
Baseline to day 28 | |
| Primary | Retention in SUD treatment | 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit. |
Baseline to 8 weeks | |
| Primary | Retention in SUD treatment | 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit. |
Baseline to three months | |
| Primary | SUD Relapse Rate | Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through: survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and biochemical verification of drug use from urine samples collected and tested every two weeks. |
Baseline to day 7 | |
| Primary | SUD Relapse Rate | Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through: survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and biochemical verification of drug use from urine samples collected and tested every two weeks. |
Baseline to day 14 | |
| Primary | SUD Relapse Rate | Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through: survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and biochemical verification of drug use from urine samples collected and tested every two weeks. |
Baseline to day 28 | |
| Primary | SUD Relapse Rate | Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through: survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and biochemical verification of drug use from urine samples collected and tested every two weeks. |
Baseline to 8 weeks | |
| Primary | SUD Relapse Rate | Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through: survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and biochemical verification of drug use from urine samples collected and tested every two weeks. |
Baseline to three months | |
| Primary | SUD engagement | SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment. | Baseline to day 14 | |
| Secondary | Opioid Craving Scale (OCS) | Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). |
Baseline to Day 7 | |
| Secondary | Cocaine Craving Questionnaire-Brief (CCQ-Brief) | Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving. |
Baseline to day 7 | |
| Secondary | Self-report instruments for Alcohol Craving | Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?" |
Baseline to day 7 | |
| Secondary | Subjective Opioid Withdrawal Scale (SOWS) | Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). |
Baseline to day 7 | |
| Secondary | Positive and Negative Affect Scales (PANAS) | Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. |
Baseline to day 7 | |
| Secondary | Opioid Craving Scale (OCS) | Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). |
Baseline to day 14 | |
| Secondary | Cocaine Craving Questionnaire-Brief (CCQ-Brief) | Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving. |
Baseline to day 14 | |
| Secondary | Self-report instruments for Alcohol Craving | Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?" |
Baseline to day 14 | |
| Secondary | Subjective Opioid Withdrawal Scale (SOWS) | Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). |
Baseline to day 14 | |
| Secondary | Positive and Negative Affect Scales (PANAS) | Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. |
Baseline to day 14 | |
| Secondary | Opioid Craving Scale (OCS) | Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). |
Baseline to Day 28 | |
| Secondary | Cocaine Craving Questionnaire-Brief (CCQ-Brief) | Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving. |
Baseline to day 28 | |
| Secondary | Self-report instruments for Alcohol Craving | Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?" |
Baseline to day 28 | |
| Secondary | Subjective Opioid Withdrawal Scale (SOWS) | Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). |
Baseline to day 28 | |
| Secondary | Positive and Negative Affect Scales (PANAS) | Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. |
Baseline to day 28 | |
| Secondary | Addiction Severity Index (ASI) | Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows: 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital. |
Baseline to day 28 | |
| Secondary | Opioid Craving Scale (OCS) | Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). |
Baseline to 8 weeks | |
| Secondary | Cocaine Craving Questionnaire-Brief (CCQ-Brief) | Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving. |
Baseline to 8 weeks | |
| Secondary | Self-report instruments for Alcohol Craving | Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?" |
Baseline to 8 weeks | |
| Secondary | Subjective Opioid Withdrawal Scale (SOWS) | Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). |
Baseline to 8 weeks | |
| Secondary | Positive and Negative Affect Scales (PANAS) | Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. |
Baseline to 8 weeks | |
| Secondary | Addiction Severity Index (ASI) | Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows: 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital. |
Baseline to 8 weeks | |
| Secondary | Opioid Craving Scale (OCS) | Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). |
Baseline to three months | |
| Secondary | Cocaine Craving Questionnaire-Brief (CCQ-Brief) | Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving. |
Baseline to three months | |
| Secondary | Self-report instruments for Alcohol Craving | Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?" |
Baseline to three months | |
| Secondary | Subjective Opioid Withdrawal Scale (SOWS) | Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). |
Baseline to three months | |
| Secondary | Positive and Negative Affect Scales (PANAS) | Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. |
Baseline to three months | |
| Secondary | Addiction Severity Index (ASI) | Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status. The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows: 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital. |
Baseline to three months |
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