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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast (Otezla) | Active Comparator | Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. |
|
| Placebo | Placebo Comparator | Identical placebo pills taken orally for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Craving to Drink | Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80. | 1 hour on the last day of dosing (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Drinking | Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value. Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing. | 11 days (Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Mason, Ph.D. | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research | La Jolla | California | 92037 | United States |
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Twenty-six subjects were excluded from study participation, twenty-two did not meet admission criteria and four declined to participate.
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 11/01/2017-04/01/2020. Seventy-seven non-treatment seeking, paid volunteers signed informed consent, Fifty-one subjects were enrolled, and Forty-three subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apremilast (Otezla) | Fixed oral dose of 90 mg/d following standard titration for a total duration of 14 days. |
| FG001 | Placebo | Placebo pill taken orally for 14 days Placebo: Oral pill, 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Apremilast (Otezla) | Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. |
| BG001 | Placebo | Placebo pill taken orally for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Craving to Drink | Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80. | All subjects who completed cue exposure testing in the laboratory were included. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 hour on the last day of dosing (Day 14) |
|
Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).
Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apremilast (Otezla) | Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara J. Mason, Ph.D. | The Scripps Research Institute | 858-784-7328 | mason@scripps.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2016 | Jul 25, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2017 | Jul 25, 2022 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2020 | Jul 25, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C505730 | apremilast |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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Parallel Assignment, Double Blind, Randomized
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| Placebo | Drug | Identical placebo pills taken orally for 14 days |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| DSM-V symptom count | Mean | Standard Deviation | Symptom count |
|
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|
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| Secondary | Drinking | Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value. Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing. | All subjects with post baseline drinking data were included. | Posted | Mean | Standard Error | Drinks per day | 11 days (Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.) |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 22 |
| 26 |
| EG001 | Placebo | Placebo pill taken orally for 14 days | 0 | 25 | 0 | 25 | 19 | 25 |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hangover | General disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
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| Mixed Models Analysis |
473 daily observations within 43 individuals. |
| 0.025 |
| Slope |
| -0.067 |
| Standard Error of the Mean |
| 0.03 |
| 2-Sided |
The apremilast group showed a significantly more rapid reduction in drinks per day relative to placebo. |
| Superiority |