Trial · NCT07247370
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility will be assessed through recruitment rates, retention to follow-up, session attendance, and treatment adherence. | 22 weeks | Feasibility outcomes will be assessed by the traffic light framework may be applied to guide progression decisions for future trials for each of the following variables: (i) time taken to recruit the sample; (ii) proportion of ineligible participants at (a) pre tele-screening and (b) onsite screening; (iii) number of participants who receive (a) at least two doses of ketamine and (b) at least four CBT sessions; (iv) retention rate over the trial. As this is the first study of its kind in this population and pilot studies are not generalisable to other contexts, these will be assessed and reported descriptively. Results will be synthesised in consideration of the feasibility to progress to larger studies, taking into account the measures described above. Specifically, based on our prior trials of CBT, pharmaco-assisted therapy and complex S9 trials, the following would be an estimation of failure to progress to full trial for each variable and when taken together: (i) \> 24 months; (ii) |
| Primary | Safety will be assessed through the frequency, severity, and relatedness of adverse events (AEs), including dissociation, affective destabilisation, and vital sign abnormalities. | 22 weeks | Safety outcomes including adverse events (AEs), serious adverse events (SAEs), and vital sign abnormalities, will be summarised descriptively across the study period. Feasibility outcomes (e.g., recruitment and retention rates, session attendance) will be analysed using proportions with corresponding 95% confidence intervals. |
| Secondary | Number of Heavy Drinking Days per week (HDDs) (>5 standard drinks/day for men; >4 for women) and total alcohol consumption. | 22 weeks | This will be measured by the Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels |
| Secondary | Change in depressive symptoms measured by MADRS and DASS-21. | 22 weeks | MADRS is a clinician-administered rating scale designed to assess the severity of depressive episodes in patients with mood disorders. It is widely used in clinical trials and psychiatric evaluations due to its sensitivity to treatment-related changes. The MADRS will be administered by trained health care professionals. The MADRS total score is calculated by summing the scores of 10 individual items, each rated on a scale from 0 to 6, yielding a total score range of 0 to 60. Higher scores indicate greater severity of depressive symptoms. The 10 items assessed in the MADRS include: Apparent sadness Reported sadness Inner tension Reduced sleep Reduced appetite Concentration difficulties Lassitude/Sluggishness Inability to feel (emotional capacity) Pessimistic thoughts Suicidal thoughts Each item is rated based on clinical judgment following a semi-structured interview, focusing on the past week. Clinically meaningful changes will be reported descriptively, including rates of ≥50% |
| Secondary | Changes in suicidal ideation (weekly monitoring) using the Columbia Suicide Severity Rating Scale (C-SSRS). | 22 weeks | The C-SSRS is a structured clinician-administered instrument with strong predictive validity for suicidal behavior, used in clinical and research settings to assess the presence, severity, and intensity of suicidal ideation and behavior. The C-SSRS is administered by trained clinicians. C-SSRS scoring includes four subscales: ideation severity (items 1-5, scored by the most severe type endorsed); intensity of ideation (sum of five items including frequency, duration, controllability, deterrents, and reasons for ideation; range 2-25; higher number indicates more intense ideation); suicidal behavior (presence or absence of actual, interrupted, aborted, or preparatory behavior recorded separately); and potential lethality (medical damage rated 0-5, potential lethality rated 0-2). At baseline, this is measured by the baseline version. At each visit following this, this will be recorded on the since last visit. Higher scores indicate more severe suicidality. |
| Secondary | Changes in Positive and Negative Mood States | Week 2 (integration session 1), Week 4 (integration session 2), Week 6 (optional - at ketamine dose 3), Week 6 (integration session 3 and end of treatment) | Mood states before/after ketamine sessions assessed by PANAS (Positive and Negative Affect Schedule). This will be measured at integration session 1 (week 2), 2 (week 4) and 3 (week 6). Used to measure an individual's emotional state, assessing two dimensions: Positive Affect (PA; captures feelings like enthusiasm and alertness), and Negative Affect (NA; measures distress and negative emotions like anger and anxiety). |
| Other | Changes in Depression | 22 weeks | Measured by cumulative scores on the DASS-21 Depression Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates greater depression. |
| Other | Changes in Anxiety | 22 weeks | Measured by cumulative scores on the DASS-21 Anxiety Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more anxiety. |
| Other | Changes in Stress | 22 weeks | Measured by cumulative scores on the DASS-21 Stress Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more stress. |
| Other | Change in Alcohol dependence severity | 22 weeks | Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence. |
| Other | Sleep Quality | 22 weeks | As measured by the PSQI (Pittsburgh Sleep Quality Index). This Index has a minimum score of 0 and a maximum score of 21. The higher the score indicates worse sleep quality. |
| Other | Executive function, cognitive flexibility and task switching | 22 weeks | To assess whether ketamine treatment improves executive functioning, specifically cognitive flexibility and task-switching ability, as measured by the Number-Letter Task (NLT). Key outcome measures include reaction time, accuracy, and switch cost (the performance difference between switch and repeat trials). Lower switch costs and faster, more accurate responses indicate improved executive control. |
| Other | Executive functioning and cognitive flexibility | 22 weeks | To assess whether ketamine treatment improves executive functioning and set-shifting, the Wisconsin Card Sorting Test (WCST) will be used. Participants are required to match stimulus cards based on varying classification principles (e.g., color, shape, number), which change without warning. Key outcome measures include the number of categories completed, total errors, perseverative responses, and perseverative errors. Higher performance is indicated by more categories completed and fewer perseverative errors, reflecting improved cognitive flexibility and executive control. |
| Other | Changes in Alcohol Urge | 22 weeks | To assess short term alcohol urge the Alcohol Urge Questionnaire (AUQ) will be used. This is a brief 8-item self-report questionnaire that evaluates acute alcohol craving as a single factor (unidimensional). Each item is rated on a Likert scale of 7 points, with higher scores indicating stronger urges to consume alcohol. Two of the questions are reversed scored. |
| Other | Psychological inflexibility | 22 weeks | As measured by the 7-item self-report Acceptance and Action Questionnaire, version 2 (AAQ-II). The items are rated on a 7-point Likert scale from 1 ("Never true") to 7 ("Always true"). Higher total scores are indicative of greater psychological inflexibility, while lower scores suggest more psychological flexibility. Scores between 24 and 28 are often used as a potential clinical cutoff indicating psychological distress. |
| Other | Severity of pain and impact on functioning | 22 weeks | Measured by The Brief Pain Inventory (BPI). Patients rate their current symptons, average experiences of pain and minimum and maximum intensities of symptoms on scales between 0 to 10. A total pain severity score can be found by averaging these individual items. Higher scores indicate greater severity and more interference. A score relating to impact on daily life can be calculated by averaging scores on each of the seven items, which also use scales from 0 to 10. Takes five minutes or less. |
| Other | Withdrawal Status | At screening and prior to dosing (22 weeks). | To determine changes in the severity of alcohol withdrawal symptoms the Revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) will be used. This 10-item scale evaluates common withdrawal symptoms including nausea/vomiting, tremor, paroxysmal sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache and orientation. Each item is rated on a scale from 0 to 7 (except orientation, which is rated 0-4), with a total score ranging from 0 to 67. Higher scores indicate more severe withdrawal symptoms. |
| Other | Drinking Diary | 22 weeks | Daily texts will be sent out to participants querying the amount of alcohol they have consumed. Participant responses to this will be recorded. This will be managed through SEMA software. |
| Other | Changes in Quality of Life | 22 weeks | To assess whether treatment can improve quality of life as measured by the World Health Organization Quality of Life (WHOQOL-BREF). This 26-item questionnaire evaluates four domains of quality of life: physical health, psychological health, social relationships, and environment. Each item is rated on a 5-point Likert scale, and domain scores are transformed to a 0-100 scale. Higher scores indicate a better quality of life. |
| Other | Treatment Satisfaction as measured by the CSQ-8 (client satisfaction questionnaire). | Week 1 (baseline) and week 10 | This instrument measures clients satisfaction with treatment. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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