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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA012870 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.
Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone and memantine | Experimental | Treatment with Naltrexone and memantine first |
|
| Naltrexone and Placebo | Placebo Comparator | Treatment with naltrexone and placebo first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone and memantine first | Drug | Naltrexone 50mg memantine 20mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Consumed at Lab Session (Day 7) | Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12. | Day 7 |
| Craving AUC: Adlib Drinking Phase | Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC. | 50-230 minutes after the priming drink during lab session |
| Stimulation Response to Alcohol at Lab Session | Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC. | 50-230 minutes after the priming drink during lab session |
| Sedation Response to Alcohol at Lab Session | Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES. As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sac, Cmhc | New Haven | Connecticut | 06519 | United States |
The number of participants enrolled was 75. However, 19 people did not start medication due to ineligibility or drop out, leaving 56 total participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone and Memantine First | Patients received Naltrexone and Memantine first in this arm. |
| FG001 | Naltrexone and Placebo First | Patients received Naltrexone and Placebo first in this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone and Memantine First | Patients in this arm received Naltrexone and Memantine first. |
| BG001 | Naltrexone and Placebo First | Patients in this arm received Naltrexone and Placebo first. |
| 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 | Number of Drinks Consumed at Lab Session (Day 7) | Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12. | Posted | Mean | Standard Deviation | drinks | Day 7 |
|
Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
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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 | Naltrexone and Memantine | Treatment with Naltrexone and memantine Naltrexone and memantine: Naltrexone 50mg memantine 20mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Cavallo, Assistant Professor | Yale University | 203974-7607 | dana.cavallo@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2016 | Jun 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Naltrexone and Placebo first | Drug | Naltrexone 50 mg Placebo |
|
|
| 50-230 minutes after the priming drink during lab session |
| Craving AUC: Priming Dose Phase | Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge. | 0-50 minutes after the priming drink |
| Sedation Response to Alcohol: Priming Dose Phase | Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed. | 0-50 minutes after priming drink |
| Stimulation Response to Alcohol: Priming Dose Phase | Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed. | 0-50 minutes after priming drink |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number of Caucasian and Non-Caucasian participants | Count of Participants | Participants |
|
| Total number of drinks over past 90 days | Timeline Followback (TLFB; Sobell & Sobell, 1996) | Mean | Standard Deviation | drinks |
|
| Drinks per drinking day in past 90 days | Mean | Standard Deviation | drinks |
|
| Percent of drinking days over past 90 days | Mean | Standard Deviation | percent of days |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Craving AUC: Adlib Drinking Phase | Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC. | Posted | Mean | Standard Deviation | log (units on a scale * minutes) | 50-230 minutes after the priming drink during lab session |
|
|
|
| Primary | Stimulation Response to Alcohol at Lab Session | Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC. | Posted | Mean | Standard Deviation | log (units on a scale *minutes) | 50-230 minutes after the priming drink during lab session |
|
|
|
| Primary | Sedation Response to Alcohol at Lab Session | Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES. As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation. | Posted | Mean | Standard Deviation | log (units on a scale *minutes) | 50-230 minutes after the priming drink during lab session |
|
|
|
| Primary | Craving AUC: Priming Dose Phase | Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge. | Posted | Mean | Standard Deviation | log (units on a scale *minutes) | 0-50 minutes after the priming drink |
|
|
|
| Primary | Sedation Response to Alcohol: Priming Dose Phase | Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed. | Posted | Mean | Standard Deviation | log (units on a scale) | 0-50 minutes after priming drink |
|
|
|
| Primary | Stimulation Response to Alcohol: Priming Dose Phase | Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed. | Posted | Mean | Standard Deviation | log (units on a scale) | 0-50 minutes after priming drink |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 3 |
| 47 |
| EG001 | Naltrexone and Placebo | Treatment with naltrexone and placebo Naltrexone and Placebo: Naltrexone 50 mg Placebo | 0 | 46 | 0 | 46 | 3 | 46 |
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| D001523 |
| Mental Disorders |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |