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Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin 1 | Experimental | Dose 1 |
|
| Placebo 1 | Placebo Comparator | Placebo 1 |
|
| Pregabalin 2 | Experimental | Dose 2 |
|
| Placebo 2 | Placebo Comparator | Placebo 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | pregabalin 2x daily for duration of study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance. | 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua A. Lile, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Human Behavioral Pharmacology | Lexington | Kentucky | 40536-0086 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 mg/Day Pregabalin, Then Placebo | 300 mg/day Pregabalin, then Placebo 150 mg then 0 mg 2x daily for duration of treatment phase |
| FG001 | Placebo, Then 300 mg/Day Pregabalin | Placebo, then 300 mg/day Pregabalin 0 mg then 150 mg 2x daily for duration of treatment phase |
| FG002 | 450 mg/Day Pregabalin, Then Placebo | 450 mg/day Pregabalin, then Placebo 225 mg then 0 mg 2x daily for duration of treatment phase |
| FG003 | Placebo, Then 450 mg/Day Pregabalin | Placebo, then 450 mg/day Pregabalin 0 mg then 225 mg 2x daily for duration of treatment phase |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (11-15 Days) |
| |||||||||||||
| Washout (6-10 Days) |
| |||||||||||||
| Third Intervention (11-15 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg/Day Pregabalin, Then Placebo | 300 mg/day Pregabalin, then Placebo 150 mg then 0 mg 2x daily for duration of treatment phase |
| BG001 | Placebo, Then 300 mg/Day Pregabalin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance. | Posted | Mean | Standard Error | Cannabis puffs | 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. |
|
22 days during maintenance on 300 mg pregabalin and matched placebo, and 30 days during maintenance on 450 mg pregabalin and matched placebo.
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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 | 300 mg/Day Pregabalin | Cannabis choice during 300 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment | associated with consumption of spoiled food |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Lile, Ph.D., Professor | University of Kentucky College of Medicine | 8593236034 | jalile2@uky.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 | Oct 28, 2020 | May 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo |
| Drug |
placebo 2x daily for duration of study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Placebo, then 300 mg/day Pregabalin
0 mg then 150 mg 2x daily for duration of treatment phase
| BG002 | 450 mg/Day Pregabalin, Then Placebo | 450 mg/day Pregabalin, then Placebo 225 mg then 0 mg 2x daily for duration of treatment phase |
| BG003 | Placebo, Then 450 mg/Day Pregabalin | Placebo, then 450 mg/day Pregabalin 0 mg then 225 mg 2x daily for duration of treatment phase |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 0 mg/Day Pregabalin (Placebo 1) |
Cannabis choice during 0 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 0 mg/day (comparator for 300 mg/day) |
| OG002 | 450 mg/Day Pregabalin | Cannabis choice during 450 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 450 mg/day |
| OG003 | 0 mg/Day Pregabalin (Placebo 2) | Cannabis choice during 0 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis Pregabalin 0 mg/day (comparator for 450 mg/day) |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | 0 mg/Day Pregabalin (Placebo 1) | Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 300 mg/day group) Placebo (0% THC) and Active (5.9% THC) Cannabis | 0 | 13 | 0 | 13 | 1 | 13 |
| EG002 | 450 mg/Day PregabalinPregabalin | Cannabis choice during 450 mg/day Pregabalin maintenance Placebo (0% THC) and Active (5.9% THC) Cannabis | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | 0 mg/Day Pregabalin (Placebo 2) | Cannabis choice during 0 mg/day Pregabalin maintenance (placebo comparator for 450 mg/day group) Placebo (0% THC) and Active (5.9% THC) Cannabis | 0 | 14 | 0 | 14 | 0 | 14 |
|
| chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | associated with injury sustained during excessive use of alcohol |
|
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| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |