Trial Outcomes & Findings for Saracatinib and Alcohol Drinking (NCT NCT02955186)

NCT ID: NCT02955186

Last Updated: 2020-11-13

Results Overview

Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline and Day 8
• Results posted on: 2020-11-13

Participant Flow

54 participants agreed to the study but 4 did not end up participating in the full study and were never randomized to treatment.

Participant milestones

Measure	125 mg Saracatinib Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Overall Study STARTED	33	17
Overall Study COMPLETED	26	15
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Measure	125 mg Saracatinib Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Overall Study Withdrawal by Subject	6	2
Overall Study Protocol Violation	1	0

Baseline Characteristics

Saracatinib and Alcohol Drinking

Baseline characteristics by cohort

Measure	125 mg Saracatinib n=33 Participants Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=17 Participants Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days	Total n=50 Participants Total of all reporting groups
Age, Continuous	29 years STANDARD_DEVIATION 7.8 • n=113 Participants	30 years STANDARD_DEVIATION 7.9 • n=163 Participants	29 years STANDARD_DEVIATION 7.8 • n=160 Participants
Sex: Female, Male Female	17 Participants n=113 Participants	8 Participants n=163 Participants	25 Participants n=160 Participants
Sex: Female, Male Male	16 Participants n=113 Participants	9 Participants n=163 Participants	25 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	11 Participants n=113 Participants	6 Participants n=163 Participants	17 Participants n=160 Participants
Race (NIH/OMB) White	21 Participants n=113 Participants	10 Participants n=163 Participants	31 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	1 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment United States	33 Participants n=113 Participants	17 Participants n=163 Participants	50 Participants n=160 Participants

PRIMARY outcome

Timeframe: Baseline and Day 8

Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1).

Outcome measures

Measure	125 mg Saracatinib n=26 Participants Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=15 Participants Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)	-1.85 drinks Standard Error .75	-2.33 drinks Standard Error .99

PRIMARY outcome

Timeframe: Baseline and Day 7

Craving for alcohol based on Yale Craving Scale (YCS), scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.

Outcome measures

Measure	125 mg Saracatinib n=33 Participants Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=17 Participants Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS	3133 units on a scale*days Standard Error 371	2876 units on a scale*days Standard Error 489

SECONDARY outcome

Timeframe: Day 8 Adlib

Biphasic Alcohol Effects Scale (BAES) scores will be used to assess stimulation. The scale ranges from 0-70, with a higher score indicating more sedated.

Outcome measures

Measure	125 mg Saracatinib n=33 Participants Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=17 Participants Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)	1650.8 units on a scale*days Standard Deviation 2185.7	1607.1 units on a scale*days Standard Deviation 1984.3

SECONDARY outcome

Timeframe: Day 8 Adlib

Biphasic Alcohol Effects Scale (BAES) scores will be used to assess sedation. The scale ranges from 0-70, with a higher score indicating more sedated.

Outcome measures

Measure	125 mg Saracatinib n=33 Participants Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=17 Participants Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)	1149.9 units on a scale*days Standard Deviation 1495.5	515.29 units on a scale*days Standard Deviation 551

Adverse Events

125 mg Saracatinib

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	125 mg Saracatinib n=33 participants at risk Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=17 participants at risk Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Injury, poisoning and procedural complications car accident	0.00% 0/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Number of events 1 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Gastrointestinal disorders hernia	3.0% 1/33 • Number of events 1 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	0.00% 0/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.

Other adverse events

Measure	125 mg Saracatinib n=33 participants at risk Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days	Placebo n=17 participants at risk Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days
Gastrointestinal disorders Abdominal Pain	9.1% 3/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Gastrointestinal disorders Diarrhea	9.1% 3/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	11.8% 2/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Gastrointestinal disorders Nausea	15.2% 5/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Gastrointestinal disorders Vomiting	0.00% 0/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	11.8% 2/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Psychiatric disorders Fatigue	6.1% 2/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	17.6% 3/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Nervous system disorders Headache	15.2% 5/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Ear and labyrinth disorders Cold symptoms	18.2% 6/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	12.1% 4/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	0.00% 0/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Musculoskeletal and connective tissue disorders Joint Pain	9.1% 3/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	0.00% 0/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Cardiac disorders Tachycardia	6.1% 2/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	11.8% 2/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Ear and labyrinth disorders Sore throat	6.1% 2/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	0.00% 0/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Nervous system disorders Dizziness	3.0% 1/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Psychiatric disorders High feeling	0.00% 0/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
Psychiatric disorders Insomnia	0.00% 0/33 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.	5.9% 1/17 • Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up. Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.

Additional Information

Dana Cavallo, Project Coordinator

Yale School of Medicine

Phone: 203-610-9788

Email: dana.cavallo@yale.edu

Results disclosure agreements

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