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Ketamine for Reduction of Alcoholic Relapse (KARE)

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ClinicalTrials.gov Identifier: NCT02649231
Recruitment Status : Completed
First Posted : January 7, 2016
Results First Posted : September 9, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Alcohol Use Disorder
Interventions Drug: Ketamine
Drug: Placebo
Behavioral: Psychological Therapy
Behavioral: Alcohol Education
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Hide Arm/Group Description

Ketamine with psychological therapy

Ketamine: 0.8 mg/kg ketamine

Psychological Therapy: Manualised relapse prevention based CBT

ketamine with alcohol education

Ketamine: 0.8 mg/kg ketamine

Alcohol Education: Simple education about alcohol effects

placebo with psychological therapy

Placebo: 0.9% saline

Psychological Therapy: Manualised relapse prevention based CBT

placebo with alcohol education

Placebo: 0.9% saline

Alcohol Education: Simple education about alcohol effects

Period Title: Overall Study
Started 24 24 23 25
Completed 20 21 21 23
Not Completed 4 3 2 2
Reason Not Completed
Adverse Event             0             0             0             1
Lost to Follow-up             2             1             1             0
Withdrawal by Subject             0             1             0             1
Protocol Violation             2             1             1             0
Arm/Group Title Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education Total
Hide Arm/Group Description

Ketamine with psychological therapy

Ketamine: 0.8 mg/kg ketamine

Psychological Therapy: Manualised relapse prevention based CBT

ketamine with alcohol education

Ketamine: 0.8 mg/kg ketamine

Alcohol Education: Simple education about alcohol effects

placebo with psychological therapy

Placebo: 0.9% saline

Psychological Therapy: Manualised relapse prevention based CBT

placebo with alcohol education

Placebo: 0.9% saline

Alcohol Education: Simple education about alcohol effects

Total of all reporting groups
Overall Number of Baseline Participants 24 24 23 25 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 23 participants 25 participants 96 participants
45.2  (8.7) 40.5  (11.1) 47.0  (11.8) 43.7  (10.2) 44.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 23 participants 25 participants 96 participants
Female
10
  41.7%
7
  29.2%
8
  34.8%
10
  40.0%
35
  36.5%
Male
14
  58.3%
17
  70.8%
15
  65.2%
15
  60.0%
61
  63.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 24 participants 24 participants 23 participants 25 participants 96 participants
24 24 23 25 96
1.Primary Outcome
Title Relapse Rates
Hide Description Time line follow back
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Hide Arm/Group Description:

Ketamine with psychological therapy

Ketamine: 0.8 mg/kg ketamine

Psychological Therapy: Manualised relapse prevention based CBT

ketamine with alcohol education

Ketamine: 0.8 mg/kg ketamine

Alcohol Education: Simple education about alcohol effects

placebo with psychological therapy

Placebo: 0.9% saline

Psychological Therapy: Manualised relapse prevention based CBT

placebo with alcohol education

Placebo: 0.9% saline

Alcohol Education: Simple education about alcohol effects

Overall Number of Participants Analyzed 21 22 21 23
Measure Type: Count of Participants
Unit of Measure: Participants
13
  61.9%
15
  68.2%
14
  66.7%
18
  78.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine+Psychological Therapy, Ketamine+Education, Placebo+Psychological Therapy, Placebo+Education
Comments Confirmed alcohol relapse by drug condition at 6 months using the Alcohol Timeline-Followback. Logistic regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and alcohol education).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.28 to 1.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage Days Abstinent
Hide Description Time line follow back
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Hide Arm/Group Description:

Ketamine with psychological therapy

Ketamine: 0.8 mg/kg ketamine

Psychological Therapy: Manualised relapse prevention based CBT

ketamine with alcohol education

Ketamine: 0.8 mg/kg ketamine

Alcohol Education: Simple education about alcohol effects

placebo with psychological therapy

Placebo: 0.9% saline

Psychological Therapy: Manualised relapse prevention based CBT

placebo with alcohol education

Placebo: 0.9% saline

Alcohol Education: Simple education about alcohol effects

Overall Number of Participants Analyzed 24 24 23 25
Mean (Standard Deviation)
Unit of Measure: percentage of days abstinent
86.4  (17.7) 82.5  (20.0) 78.3  (26.9) 70.7  (25.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine+Psychological Therapy, Ketamine+Education, Placebo+Psychological Therapy, Placebo+Education
Comments Linear regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and psychoeducation). Only participants with a minimum of 159 days of completed drinking self-report data were included in the main ITT analysis as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.1
Confidence Interval (2-Sided) 95%
1.1 to 19.0
Estimation Comments [Not Specified]
Time Frame Screening visit (visit 1) to 6 month follow-up visit (visit 10).Participants were asked about any potential adverse events at the beginning of each visit.
Adverse Event Reporting Description Participants were asked about any potential adverse events at the beginning of each visit.
 
Arm/Group Title Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Hide Arm/Group Description

Ketamine with psychological therapy

Ketamine: 0.8 mg/kg ketamine

Psychological Therapy: Manualised relapse prevention based CBT

ketamine with alcohol education

Ketamine: 0.8 mg/kg ketamine

Alcohol Education: Simple education about alcohol effects

placebo with psychological therapy

Placebo: 0.9% saline

Psychological Therapy: Manualised relapse prevention based CBT

placebo with alcohol education

Placebo: 0.9% saline

Alcohol Education: Simple education about alcohol effects

All-Cause Mortality
Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/23 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      2/23 (8.70%)      1/25 (4.00%)    
General disorders         
Alcohol intoxication   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  3
Infections and infestations         
Kidney infection   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Injury, poisoning and procedural complications         
Brain hemorrhage   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Skull fracture   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Pregnancy, puerperium and perinatal conditions         
Abdominal pain  [1]  0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Abdominal pain secondary to spontaneous abortion
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Ketamine+Psychological Therapy Ketamine+Education Placebo+Psychological Therapy Placebo+Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/24 (54.17%)      17/24 (70.83%)      16/23 (69.57%)      17/25 (68.00%)    
Blood and lymphatic system disorders         
ALT and AST increase in blood test   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Chronic lymphocytic leukaemia diagnosis   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Low folic acid   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Swollen glands   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Cardiac disorders         
Tachycardia   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Hypotension   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Eye disorders         
Visual distortions   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders         
Constipation   0/24 (0.00%)  0 1/24 (4.17%)  1 1/23 (4.35%)  1 0/25 (0.00%)  0
Diarrhoea   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Thirst   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Loss of appetite   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Nausea   1/24 (4.17%)  1 1/24 (4.17%)  1 0/23 (0.00%)  0 1/25 (4.00%)  1
Vomiting   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
General disorders         
Fatigue   3/24 (12.50%)  3 6/24 (25.00%)  10 0/23 (0.00%)  0 4/25 (16.00%)  7
Influenza   1/24 (4.17%)  1 1/24 (4.17%)  2 1/23 (4.35%)  1 0/25 (0.00%)  0
Insomnia   2/24 (8.33%)  4 2/24 (8.33%)  4 2/23 (8.70%)  2 2/25 (8.00%)  4
Mental confusion   1/24 (4.17%)  1 2/24 (8.33%)  2 0/23 (0.00%)  0 2/25 (8.00%)  3
Unsteadiness   1/24 (4.17%)  2 2/24 (8.33%)  2 0/23 (0.00%)  0 1/25 (4.00%)  1
Lack of coordination   1/24 (4.17%)  1 2/24 (8.33%)  2 0/23 (0.00%)  0 0/25 (0.00%)  0
Ankle pain   1/24 (4.17%)  1 0/24 (0.00%)  0 1/23 (4.35%)  1 1/25 (4.00%)  1
Chest pain   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Elbow pain   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Joint pain   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 1/25 (4.00%)  1
Knee pain   1/24 (4.17%)  1 1/24 (4.17%)  1 1/23 (4.35%)  1 0/25 (0.00%)  0
Stomach pain   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Toe pain   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 1/25 (4.00%)  1
Cannula (for infusion) blocked   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Feeling cold   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Fever   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Hot flush   1/24 (4.17%)  2 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Suicidal ideation   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Hepatobiliary disorders         
Aspartate aminotransferase increased   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Liver function test increased   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Immune system disorders         
Allergic reaction insect bites   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Infections and infestations         
Herpes labialis   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Finger infection   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Fungal infection  [1]  0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Mouth ulcer   1/24 (4.17%)  1 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Oral candidiasis   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Injury, poisoning and procedural complications         
Haematoma   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 4/25 (16.00%)  7
Anaesthetic shivers   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Broken thumb   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Cut heel  [2]  0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Cut finger   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Cut at wrist  [3]  0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Scratch to forehead  [4]  0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Finger fracture   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Hospitalisation due to morphine overdose   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Injured coccyx   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
IV cannula infiltration   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Sprained ankle   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Whiplash associated disorder   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Wrist sprain   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain   1/24 (4.17%)  1 1/24 (4.17%)  1 0/23 (0.00%)  0 2/25 (8.00%)  3
Muscle pain   0/24 (0.00%)  0 0/24 (0.00%)  0 2/23 (8.70%)  2 0/25 (0.00%)  0
Neck pain   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Shoulder pain   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 2/25 (8.00%)  3
Arthritis   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Bursitis   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Carpal tunnel syndrome   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Muscle strain thorax   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Strained gluteus maximus   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Stiff neck   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Tendonitis   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Toothache   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 1/25 (4.00%)  2
Nervous system disorders         
Dizziness   2/24 (8.33%)  2 1/24 (4.17%)  1 2/23 (8.70%)  2 0/25 (0.00%)  0
Headache   3/24 (12.50%)  6 4/24 (16.67%)  5 2/23 (8.70%)  2 8/25 (32.00%)  15
Impaired concentration   0/24 (0.00%)  0 4/24 (16.67%)  6 1/23 (4.35%)  1 2/25 (8.00%)  3
Memory impairment   1/24 (4.17%)  1 3/24 (12.50%)  3 0/23 (0.00%)  0 2/25 (8.00%)  2
Altered Time perception   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Bodily numbness   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Laceration to forehead due to fall during seizure   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Restless legs syndrome   1/24 (4.17%)  2 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Migraine   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  2
Vasovagal syncope   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Psychiatric disorders         
Anxiety   2/24 (8.33%)  3 1/24 (4.17%)  1 3/23 (13.04%)  3 3/25 (12.00%)  3
Depressed mood   4/24 (16.67%)  5 12/24 (50.00%)  15 7/23 (30.43%)  8 6/25 (24.00%)  7
Anger   0/24 (0.00%)  0 1/24 (4.17%)  1 1/23 (4.35%)  1 0/25 (0.00%)  0
Emotional distress during talking session   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Emotionally unstable   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Euphoric mood   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Feelings of altered reality   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Flat affect   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Lethargy   1/24 (4.17%)  3 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Loss of interest in activities   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Mood fluctuations   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Nervousness   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Passive suicidal thoughts   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Seizure during alcohol withdrawal   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Tearfulness   2/24 (8.33%)  3 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Renal and urinary disorders         
Cystitis   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 1/25 (4.00%)  1
Haematuria   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Reproductive system and breast disorders         
Dysmenorrhoea   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 1/25 (4.00%)  2
Erection  [5]  0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Throat irritation   0/24 (0.00%)  0 1/24 (4.17%)  1 1/23 (4.35%)  1 2/25 (8.00%)  2
Viral rhinitis   1/24 (4.17%)  1 2/24 (8.33%)  4 2/23 (8.70%)  3 4/25 (16.00%)  4
Bronchitis   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Chest infection   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Cough   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 1/25 (4.00%)  1
Coughing up blood   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Lower respiratory tract infection   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Nasal congestion   0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin rash arm   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 2/25 (8.00%)  5
Skin rash leg   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 2/25 (8.00%)  2
Dry skin   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Skin irritation   1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/25 (0.00%)  0
Two red bumps around eyes   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Surgical and medical procedures         
Arm pain  [6]  1/24 (4.17%)  2 1/24 (4.17%)  1 0/23 (0.00%)  0 0/25 (0.00%)  0
Dental implantation   0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0
Hernia repair   0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/25 (4.00%)  1
Vascular disorders         
Hypertension   1/24 (4.17%)  1 2/24 (8.33%)  2 0/23 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
[1]
Both hands
[2]
Caused by SCRAM device
[3]
Accident
[4]
After fall
[5]
During infusion
[6]
Pain in arm were cannula was administered/ blood was taken from.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Celia Morgan
Organization: University of Exeter
Phone: 01392 724649
EMail: Celia.Morgan@exeter.ac.uk
Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02649231    
Other Study ID Numbers: 13/0253.
First Submitted: January 5, 2016
First Posted: January 7, 2016
Results First Submitted: August 5, 2021
Results First Posted: September 9, 2021
Last Update Posted: September 9, 2021