Trial Outcomes & Findings for Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland (NCT NCT01100853)

NCT ID: NCT01100853

Last Updated: 2018-03-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2018-03-06

Participant Flow

Participant milestones

Measure	VIVITROL Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Overall Study STARTED	51	49
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	27	23

Reasons for withdrawal

Measure	VIVITROL Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Overall Study Lost to Follow-up	11	6
Overall Study Received <4 study injections	10	13
Overall Study Withdrawal by Subject	6	4

Baseline Characteristics

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Baseline characteristics by cohort

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.51 years STANDARD_DEVIATION 1.11 • n=5 Participants	31.59 years STANDARD_DEVIATION 1.34 • n=7 Participants	31.55 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment Iceland	51 participants n=5 Participants	49 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Urine drug screens negative amphetamine

Outcome measures

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Number Negative Urines (Proportion Negative Urines)	560 Urine Drug Screen	634 Urine Drug Screen

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Number Negative Urines (Proportion Negative Urines) Amphetamine	560 Urine Drug Screen	634 Urine Drug Screen

SECONDARY outcome

Timeframe: 24 weeks

The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.

Outcome measures

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Amphetamine Craving Scale	40.9 VAS Score Standard Deviation 4	46.92 VAS Score Standard Deviation 4.38

SECONDARY outcome

Timeframe: 24 weeks

The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.

Outcome measures

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Beck Depression Inventory	14.63 BDI Score Standard Deviation 1.40	14.08 BDI Score Standard Deviation 1.09

SECONDARY outcome

Timeframe: 24 weeks

The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.

Outcome measures

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Risk Assessment Battery	7.14 Total Score Standard Deviation .62	5.98 Total Score Standard Deviation .43

SECONDARY outcome

Timeframe: Baseline

Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.

Outcome measures

Measure	VIVITROL Injection, 24 Weeks n=51 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 Participants Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Prior Admissions to Vogur Hospital	5.78 Number of admissions Standard Deviation .87	4.88 Number of admissions Standard Deviation .63

Adverse Events

VIVITROL Injection, 24 Weeks

Serious events: 9 serious events

Other events: 28 other events

Deaths: 0 deaths

VIVITROL Placebo Injection, 24 Weeks

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	VIVITROL Injection, 24 Weeks n=51 participants at risk Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 participants at risk Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Psychiatric disorders Hospitilization due to relapse to substance disorder	13.7% 7/51 • Number of events 11	12.2% 6/49 • Number of events 6
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/51	2.0% 1/49 • Number of events 1
Hepatobiliary disorders Abdominal pain, elevated liver enzymes	2.0% 1/51 • Number of events 1	0.00% 0/49
Psychiatric disorders Potential suicide attempt	2.0% 1/51 • Number of events 1	0.00% 0/49

Other adverse events

Measure	VIVITROL Injection, 24 Weeks n=51 participants at risk Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)	VIVITROL Placebo Injection, 24 Weeks n=49 participants at risk Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Gastrointestinal disorders Nausea, diarrhea, discomfort/pain from stomach, heartburn	15.7% 8/51 • Number of events 12	14.3% 7/49 • Number of events 13
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/51	10.2% 5/49 • Number of events 8
Psychiatric disorders Symptoms of depression and/or anxiety	9.8% 5/51 • Number of events 5	4.1% 2/49 • Number of events 2
Nervous system disorders Dizziness, fatigue, fainting sensation	11.8% 6/51 • Number of events 7	6.1% 3/49 • Number of events 3
Hepatobiliary disorders Elevated ALT level >5 times normal range	2.0% 1/51 • Number of events 1	4.1% 2/49 • Number of events 2
General disorders Headache	7.8% 4/51 • Number of events 6	10.2% 5/49 • Number of events 6
General disorders Other, feeling unwell, fever, loss of appetite, joint pain, pruritus, sore throat, etc.	7.8% 4/51 • Number of events 9	6.1% 3/49 • Number of events 7

Additional Information

Dr. Helen Pettinati

University of Pennsylvania

Phone: 215-222-3200

Email: helenp@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place