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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA027124 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone and placebo | Active Comparator | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. |
|
| Naltrexone and dronabinol | Experimental | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injectable naltrexone and dronabinol | Drug | Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) . | The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged. | 3x/week during 8 weeks of the trial or study participation |
| Retention | Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment. | retention over 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Bisaga, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone and Placebo | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks. |
| FG001 | Naltrexone and Dronabinol | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone and Placebo | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks. |
| BG001 |
| 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 | Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) . | The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged. | Posted | Mean | Standard Deviation | units on a scale | 3x/week during 8 weeks of the trial or study participation |
|
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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 Placebo | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritis and facial swelling | General disorders | Systematic Assessment | A participant in the dronabinol treatment arm developed symptoms of pruritis and facial swelling two days after receiving an injection of naltrexone. A dermatologist determined that the rash was most likely not related to the study medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Bisaga | NYS Psychiatric Institute | 646-774-6155 | amb107@columbia.edu |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Naltrexone and placebo | Drug | Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks. |
|
| Naltrexone and Dronabinol |
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Naltrexone and Dronabinol | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. |
|
|
| Primary | Retention | Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment. | Posted | Number | participants | retention over 8 weeks. |
|
|
|
| 2 |
| 20 |
| 10 |
| 20 |
| EG001 | Naltrexone and Dronabinol | A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment. Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. | 1 | 40 | 28 | 40 |
|
| Dehydration | General disorders | Systematic Assessment | One participant in the placebo arm was hospitalized for symptoms of dehydration during the first week of the outpatient phase. |
|
| Kidney infection and dislocated arm | General disorders | Systematic Assessment | A participant in the placebo arm was hospitalized for treatment of a kidney infection and dislocated arm, which occurred 3 weeks after discontinuation of study participation |
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| Mood changes | Psychiatric disorders | Systematic Assessment |
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| Increased/decreased appetite | General disorders | Systematic Assessment |
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| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Body Aches | General disorders | Systematic Assessment |
|
| GI Distress | Gastrointestinal disorders | Systematic Assessment |
|
| Sweating/chills | General disorders | Systematic Assessment |
|
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| D009270 |
| Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | 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 |