A Phase 2/3 interventional study of Tramadol and Placebo in Substance Withdrawal Syndrome, sponsored by Michelle Lofwall. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Michelle Lofwall · Phase 2/3, Interventional, and Treatment
Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.
128 studies on the registry are indexed under Substance Withdrawal Syndrome; 8 are open to participants now.
This study's enrollment of 53 is close to the median of 53 across 93 interventional studies indexed under Substance Withdrawal Syndrome.
Browse Substance Withdrawal Syndrome studies →This is the only study on the registry with Michelle Lofwall as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tramadol 200 mg daily for 1 week then placebo given for 1 week
Drug: Tramadol
Medication
Drug: Placebo
Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Drug: Tramadol
Oral Medication
Also known as: Brand name example: Ultram
Oral Medication
Also known as: Placebo is like a sugar pill
Subjective Opioid Withdrawal Total Adjective Score
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Time frame: Days 1-7
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Time frame: Days 1-7
Subjective Opioid Withdrawal Adjective Total Score Week 2
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Time frame: days 8-13
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Time frame: Days 8-13 (all groups now on placebo)
Outpatient screening. Recruitment by advertisement and word or mouth.
| Milestone | Tramadol 200 mg Daily | Placebo | Tramadol 600 mg Daily |
|---|---|---|---|
| Started | 17 | 19 | 17 |
| Completed | 12 | 12 | 12 |
| Not completed | 5 | 7 | 5 |
| Withdrew: Withdrawal by subject | 5 | 7 | 3 |
| Withdrew: Protocol violation | 0 | 0 | 2 |
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
| units on a scale | Tramadol 200 mg Daily | Placebo | Tramadol 600 mg Daily |
|---|---|---|---|
| Subjective Opioid Withdrawal Total Adjective Score | 5.8 ± 0.1 | 7.7 ± 0.1 | 6.9 ± 0.1 |
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
| Mean doses per day | Tramadol 200 mg Then Placebo | Placebo for Two Weeks | Tramadol 600 mg Then Placebo |
|---|---|---|---|
| Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1 | 1.8 ± 0.2 | 2.5 ± 0.2 | 3.1 ± 0.3 |
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
| units on a scale | Tramadol 200 mg Then Placebo | Placebo for Two Weeks | Tramadol 600 mg Then Placebo |
|---|---|---|---|
| Subjective Opioid Withdrawal Adjective Total Score Week 2 | 2.7 ± 0.2 | 2.9 ± 0.2 | 2.7 ± 0.1 |
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
| mean # of doses per day | Tramadol 200 mg Then Placebo | Placebo for Two Weeks | Tramadol 600 mg Then Placebo |
|---|---|---|---|
| Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2 | 1.8 ± 0.2 | 1.6 ± 0.1 | 3.2 ± 0.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tramadol 200 mg | — | 0/17 (0%) | 2/17 (11.8%) |
| Placebo | — | 0/19 (0%) | 1/19 (5.3%) |
| Tramadol 600 mg | — | 0/17 (0%) | 2/17 (11.8%) |
| Event | Tramadol 200 mg | Placebo | Tramadol 600 mg |
|---|---|---|---|
| unsteady urine flow without dysuriaRenal and urinary disorders | 0/17 | 0/19 | 1/17 |
| sore throat/strep BInfections and infestations | 0/17 | 0/19 | 1/17 |
| abdominal painGastrointestinal disorders | 1/17 | 1/19 | 0/17 |
| fleeting chest painMusculoskeletal and connective tissue disorders | 1/17 | 0/19 | 0/17 |
| tooth painMusculoskeletal and connective tissue disorders | 0/17 | 0/19 | 1/17 |
| flank painMusculoskeletal and connective tissue disorders | 0/17 | 0/19 | 1/17 |
| sore throat with coughInfections and infestations | 0/17 | 0/19 | 1/17 |
| athletes footInfections and infestations | 1/17 | 0/19 | 0/17 |
| left shoulder painMusculoskeletal and connective tissue disorders | 0/17 | 1/19 | 0/17 |
The study was a priori defined to evaluate only completers. There were 12 completers in each of the three study arms. We retained the description of the completers because it corresponds to the primary outcomes results that are reported (and this is what was proposed a priori and approved by NIDA review).
| Age, Categorical(Participants) | Tramadol 200 mg | Placebo | Tramadol 600 mg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 12 | 12 | 36 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Tramadol 200 mg | Placebo | Tramadol 600 mg | Total |
|---|---|---|---|---|
| Mean | 26.8 ± 0.9 | 32.2 ± 2.2 | 31.6 ± 1.5 | 30.1 ± 1.5 |
| Sex: Female, Male(Participants) | Tramadol 200 mg | Placebo | Tramadol 600 mg | Total |
|---|---|---|---|---|
| Female | 5 | 4 | 5 | 14 |
| Male | 7 | 8 | 7 | 22 |
| Region of Enrollment(participants) | Tramadol 200 mg | Placebo | Tramadol 600 mg | Total |
|---|---|---|---|---|
| United States | 12 | 12 | 12 | 36 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Substance Withdrawal Syndrome→