Trial Outcomes & Findings for Pharmacogenetic Response to Naltrexone For Alcohol Dependence (NCT NCT00831272)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

221 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-05-11

Participant Flow

A sample of participants was recruited through advertisements in local media, referrals from physicians, or self-referrals. Recruitment occurred between January 2009 and September 2013. Participants were recruited from 5 sites.

Participant milestones

Participant milestones
Measure	Naltrexone Group ASP 40 Group 50mg/day of naltrexone and ASP 40 carrier	Placebo Group ASP 40 Group Placebo group and ASP 40 carrier	Naltrexone Group ASN 40 Group Naltrexone 50mg/day and ASN 40 carrier	Placebo Group ASN 40 Group Placebo plus ASN 40 Carrier
Overall Study STARTED	38	44	73	66
Overall Study COMPLETED	30	37	63	56
Overall Study NOT COMPLETED	8	7	10	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenetic Response to Naltrexone For Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone Group ASP 40 Group n=38 Participants 50mg/day of naltrexone and ASP 40 carrier	Placebo Group ASP 40 Group n=44 Participants Placebo group and ASP 40 carrier	Naltrexone Group ASN 40 Group n=73 Participants Naltrexone 50mg/day and ASN 40 carrier	Placebo Group ASN 40 Group n=66 Participants Placebo plus ASN 40 Carrier	Total n=221 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 13.4 • n=99 Participants	46.9 years STANDARD_DEVIATION 11.8 • n=107 Participants	51.2 years STANDARD_DEVIATION 13.0 • n=206 Participants	48.2 years STANDARD_DEVIATION 11.9 • n=7 Participants	48.2 years STANDARD_DEVIATION 12.7 • n=31 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants	11 Participants n=7 Participants	31 Participants n=31 Participants
Sex: Female, Male Male	34 Participants n=99 Participants	38 Participants n=107 Participants	63 Participants n=206 Participants	55 Participants n=7 Participants	190 Participants n=31 Participants
% Days Heavy Drinking	68 % days of heavy drinking STANDARD_DEVIATION 29.8 • n=99 Participants	72.5 % days of heavy drinking STANDARD_DEVIATION 27.8 • n=107 Participants	67.5 % days of heavy drinking STANDARD_DEVIATION 26.8 • n=206 Participants	70.9 % days of heavy drinking STANDARD_DEVIATION 28 • n=7 Participants	69.9 % days of heavy drinking STANDARD_DEVIATION 27.4 • n=31 Participants
% Days Drinking	78.9 % days of any drinking STANDARD_DEVIATION 23.1 • n=99 Participants	82.7 % days of any drinking STANDARD_DEVIATION 20.9 • n=107 Participants	82.8 % days of any drinking STANDARD_DEVIATION 20.2 • n=206 Participants	82.5 % days of any drinking STANDARD_DEVIATION 19.8 • n=7 Participants	81.9 % days of any drinking STANDARD_DEVIATION 20.7 • n=31 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Repeated weekly measures of drinking outcomes were compared using generalized estimating equation models (GEE). The explanatory variables of primary interest comprised binary indicators for intervention group, genotype, and their interaction, a linear trend for time, and terms for interactions involving time and the group and genotype factors.

Outcome measures

Outcome measures
Measure	Naltrexone Group ASP 40 Group n=38 Participants 50mg/day of naltrexone and ASP 40 carrier	Placebo Group ASP 40 Group n=44 Participants Placebo group and ASP 40 carrier	Naltrexone Group ASN 40 Group n=73 Participants Naltrexone 50mg/day and ASN 40 carrier	Placebo Group ASN 40 Group n=66 Participants Placebo plus ASN 40 Carrier
Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial.	18.9 percentage of heavy drinking days Standard Deviation 21.7	17.9 percentage of heavy drinking days Standard Deviation 21.8	14.5 percentage of heavy drinking days Standard Deviation 19.0	21.7 percentage of heavy drinking days Standard Deviation 25.7

Adverse Events

Naltrexone Group ASP 40 Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Group ASP 40 Group

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Naltrexone Group ASN 40 Group

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Group ASN 40 Group

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Naltrexone Group ASP 40 Group n=38 participants at risk 50mg/day of naltrexone and ASP 40 carrier	Placebo Group ASP 40 Group n=44 participants at risk Placebo group and ASP 40 carrier	Naltrexone Group ASN 40 Group n=73 participants at risk Naltrexone 50mg/day and ASN 40 carrier	Placebo Group ASN 40 Group n=66 participants at risk Placebo plus ASN 40 Carrier
Psychiatric disorders inpatient detoxification	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	2.3% 1/44 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.4% 1/73 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.5% 1/66 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Psychiatric disorders Suicide Attempt	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/44 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/73 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.5% 1/66 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Endocrine disorders Hospitlized	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	2.3% 1/44 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/73 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/66 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.

Other adverse events

Other adverse events
Measure	Naltrexone Group ASP 40 Group n=38 participants at risk 50mg/day of naltrexone and ASP 40 carrier	Placebo Group ASP 40 Group n=44 participants at risk Placebo group and ASP 40 carrier	Naltrexone Group ASN 40 Group n=73 participants at risk Naltrexone 50mg/day and ASN 40 carrier	Placebo Group ASN 40 Group n=66 participants at risk Placebo plus ASN 40 Carrier
Gastrointestinal disorders GI complaints	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/44 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.4% 1/73 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.5% 1/66 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Psychiatric disorders Pain	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	2.3% 1/44 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.4% 1/73 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.5% 1/66 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Gastrointestinal disorders Nausea	2.6% 1/38 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/44 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/73 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/66 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Reproductive system and breast disorders Change in libido	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/44 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.4% 1/73 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.5% 1/66 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Psychiatric disorders Headache	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	2.3% 1/44 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/73 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/66 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.
Psychiatric disorders Sleep	0.00% 0/38 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/44 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	1.4% 1/73 • Number of events 1 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.	0.00% 0/66 • Adverse events were ascertained weekly. AE's were only counted if reported at a level of moderate to severe by patient self report.

Additional Information

David Oslin

University of Pennsylvania

Phone: 215 823 5894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place