Trial Outcomes & Findings for Network Support for Alcohol Treatment 2 (NCT NCT01129804)

NCT ID: NCT01129804

Last Updated: 2021-11-02

Results Overview

PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 193 participants
• Primary outcome timeframe: Every 3 months out to 2 years
• Results posted on: 2021-11-02

Participant Flow

Participant milestones

Measure	Network Support Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Packaged Cognitive-Behavioral Treatment The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Overall Study STARTED	96	97
Overall Study COMPLETED	64	66
Overall Study NOT COMPLETED	32	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Network Support for Alcohol Treatment 2

Baseline characteristics by cohort

Measure	Network Support n=96 Participants Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Packaged Cognitive-Behavioral Treatment n=97 Participants The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Total n=193 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	96 Participants n=5 Participants	97 Participants n=7 Participants	193 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	47.2 years STANDARD_DEVIATION 11.2 • n=5 Participants	45.1 years STANDARD_DEVIATION 9.8 • n=7 Participants	46.01 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	68 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	94 Participants n=7 Participants	187 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants	93 Participants n=7 Participants	185 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants	97 participants n=7 Participants	193 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months out to 2 years

Population: Men and women aged 18-65 diagnosed with alcohol use disorder, moderate to severe.

PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.

Outcome measures

Measure	Network Support n=96 Participants Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Packaged Cognitive-Behavioral Treatment n=97 Participants The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Proportion Days Abstinent (PDA)	.67 proportion of days abstinent Standard Deviation .33	.73 proportion of days abstinent Standard Deviation .33

SECONDARY outcome

Timeframe: assessed every 6 months out to 2 years, mean change over 2 years reported

Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.

Outcome measures

Measure	Network Support n=96 Participants Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Packaged Cognitive-Behavioral Treatment n=97 Participants The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Social Network Change	.35 score on a scale Standard Error .05	.30 score on a scale Standard Error .05

Adverse Events

Network Support

Serious events: 30 serious events

Other events: 5 other events

Deaths: 2 deaths

Packaged Cognitive-Behavioral Treatment

Serious events: 35 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	Network Support n=96 participants at risk Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Packaged Cognitive-Behavioral Treatment n=97 participants at risk The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Nervous system disorders Increased drinking from baseline	31.2% 30/96 • Number of events 30 • 27 months	36.1% 35/97 • Number of events 35 • 27 months

Other adverse events

Measure	Network Support n=96 participants at risk Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.	Packaged Cognitive-Behavioral Treatment n=97 participants at risk The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking. Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking.
Psychiatric disorders Suicidal Ideation	5.2% 5/96 • Number of events 5 • 27 months	5.2% 5/97 • Number of events 5 • 27 months

Additional Information

Mark D. Litt, PhD; Principal Investigator

UConn Health

Phone: 860-679-4680

Email: litt@uchc.edu

Results disclosure agreements

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