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VIVITROL as a Treatment for Cocaine and Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT00777062
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : January 29, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
Alkermes, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Cocaine Dependence
Alcohol Dependence
Interventions Drug: VIVITROL (Naltrexone extended-release injectable suspension)
Drug: Placebo
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vivitrol Placebo
Hide Arm/Group Description VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6 Placebo injection, 380 mg injection at the start of weeks 2 and 6.
Period Title: Overall Study
Started 39 41
Completed 36 36
Not Completed 3 5
Arm/Group Title Vivitrol Placebo Total
Hide Arm/Group Description VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6 Placebo injection, 380 mg injection at the start of weeks 2 and 6. Total of all reporting groups
Overall Number of Baseline Participants 39 41 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
41
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 41 participants 80 participants
47.5  (7.0) 48.4  (6.3) 47.9  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
Female
9
  23.1%
6
  14.6%
15
  18.8%
Male
30
  76.9%
35
  85.4%
65
  81.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 41 participants 80 participants
39 41 80
1.Primary Outcome
Title Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.
Hide Description Percentage of subjects with no cocaine use for at least 3 weeks
Time Frame 8 week medication phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vivitrol Placebo
Hide Arm/Group Description:
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of Participants
33.3 31.7
2.Primary Outcome
Title Time Line Follow Back -Reported Days of Abstinence From Drinking
Hide Description Percentage of participants who were abstinent from drinking
Time Frame 8 week medication phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vivitrol Placebo
Hide Arm/Group Description:
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of Participants
10.3 17.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vivitrol Placebo
Hide Arm/Group Description VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6 Placebo injection, 380 mg injection at the start of weeks 2 and 6.
All-Cause Mortality
Vivitrol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Vivitrol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/39 (12.82%)      4/41 (9.76%)    
Gastrointestinal disorders     
Hospitalization for nausea and vomiting [1]  1/39 (2.56%)  1 0/41 (0.00%)  0
General disorders     
Hospitalization for pneumonia [2]  0/39 (0.00%)  0 1/41 (2.44%)  1
Worsening of addiction symptoms [3]  1/39 (2.56%)  1 1/41 (2.44%)  1
Injury, poisoning and procedural complications     
Lacerations and fractured rib [4]  0/39 (0.00%)  0 1/41 (2.44%)  1
Hospitalization for an overdose of tylenol  1/39 (2.56%)  1 0/41 (0.00%)  0
Psychiatric disorders     
Hospitalization for Depression  1/39 (2.56%)  1 1/41 (2.44%)  1
Skin and subcutaneous tissue disorders     
Injection Site Reaction [5]  1/39 (2.56%)  1 0/41 (0.00%)  0
[1]
Participant said nausea was resolved on 3/7/10 and did not receive second injection. He finished his final study visit on 4/12/10.
[2]
Participant complained of feeling ill and very fatigued. He had a high fever on 8/5/11, so study nurse recommended that he go to the ER. He was admitted on 8/5/11 with pneumonia, and released on 8/9/11.
[3]
Participant entered inpatient treatment for worsening of addiction symptoms.
[4]
Participant was physically attacked and hospitalized for injuries.
[5]
Participant sent to dermatology clinic and they recommended monitoring the site, but no urgent action needed. Participant t finished out study visits and swelling went down.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vivitrol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/39 (56.41%)      13/41 (31.71%)    
Skin and subcutaneous tissue disorders     
Swelling at the injection site  22/39 (56.41%)  13/41 (31.71%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kyle Kampman
Organization: University of Pennsylvania
Phone: 215-222-3200 ext 109
EMail: kampman@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00777062    
Other Study ID Numbers: 808641
5P50DA012756-10 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: December 12, 2013
Results First Posted: January 29, 2014
Last Update Posted: January 26, 2018